RESPIRONICS INC.

FDA Device Registration & Listing · MURRYSVILLE, PA, US · Registration 2518422

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2518422
FEI Number
2518422
Entity Name
RESPIRONICS INC.
City/State/Country
MURRYSVILLE, PA, US
Establishment Address
1001 Murry Ridge Lane, MURRYSVILLE, PA 15668, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Philips Medical Systems International BV (Owner Number: 2518422)
Owner / Operator Contact Address
Veenpluis 6, Best, NL-NOTA 5684PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K110398
PMA Number
N/A

All Registered Proprietary Names

DirectView Data Management System Encore Anywhere A40 Heated Humidifier OMNILAB DIRECT Universal Battery Pack (UBP2) BiPAP A40 Ventilatory Support System PC Direct Omnilab Direct Omnilab Advanced/Advanced + BiPAP autoSV Advanced System One BiPAP w/ & w/o Humidifier DreamStation BiPAP autoSV w/ & w/o Humidifier DreamStation BiPAP S/T w/ & w/o Humidifier DreamStation BiPAP AVAPS w/ & w/o Humidifier AF531 FFM AF541 FFM AF421 FFM Quantum Respiratory Effort Sensor Heated Humidifier - HC500 Cannula Style Thermocouples Performance Tubing 6' DreamStation BiPAP Auto w/ & w/o Humidifier Dreamstation CPAP Auto w/ & w/o Humidifier REMstar Auto A-flex HT (Q-series) DreamStation CPAP w/ & w/o Humidifier Dreamstation CPAP Pro w/ & w/o Humidifier DreamStation BiPAP Pro w/ & w/o Humidifier DreamStation Go CPAP DreamStation Go Auto CPAP Dreamstation GO w/ & w/o Humidifier DreamStation CPAP Assist BiliChek Threshold Pep NightBalance Dreamstation 2 Advanced System Dreamstation 2 System Alice PDX Nonin Finger Oximeter Multiple - Invasive Flex Trach Adaptor 15 cm, 22M/15F-15F Flex Trach Adaptor 15 cm, 22M/15F-22F SmartSleep, Deep Sleep Headband V60 with PPV and Auto-Trak + Disposable Swivel Passive Exhalation Port Whisper Swivel II Spectrum Actiwatch Score Shimmer Full Face Mask S/M/L/MW Dreamwear Full Med Frm w/HGR BiPAP S/T ventilatory support system BiPAP AVAPS ventilatory support system Universal Battery Pack (UBP2) Trilogy 202 Ventilator Trilogy Nurse Call Adaptor Cable Performax FitLife SE Total Face Mask Nuance and Nuance Pro Nasal Pillow Mask Trilogy Evo Roll Stand – RIMR Roll Stand, OmniLab Advanced + - RIMR DreamStation 2 Roll Stand – RIST Trilogy Evo Mounting Bracket - RIMR Trilogy Evo Wheelchair Mount – RIMR Roll Stand, BiPAP A-series – RIMR DreamStation Roll Stand - RIST SPRS-2 Roll Stand, H-111 cm, EV300 Mount REMstar SE CPAP Dorma CPAP Universal Battery Pack (UBP2) RUSleeping Crystal Trace Piezo Sensor Bronchoscopy Elbow, Click Style Bronchoscopy elbow AF541 SE Full Face Mask Chin Strap Headgear FFM PTrak FFM Performax, FitLife EE Total Face Mask Trilogy Nurse Call Adaptor Cable Trilogy Evo Ventilator Nurse Call Rj9 Adapter Cable Open Dual Limb Active Exhalation Valve Nurse Call Adaptor Cable – Alarm Open/Closed Trilogy EV300 12/24V Battery Cable w/terminals or adapter External Flow Sensor Assembly Adult/Pediatric OR Pediatric/Infant Performax Pediatric SE Total FFM CPAP VALVES Dreamwear Silicone Pillows Mask DreamStation Link Module (RIST) Payer Integration Software (RIMR) Omnilab Conncect (RIMR) AOM (RIMR) Sleepmapper (RIMR) DreamStation Wi-Fi Accessory (RIST) HL7 Interface Utility (RIMR) DreamStation Cellular Modem (RIST) PR1 Wired/Wireless Modems (RIST) DreamMapper FloTrak CO2 Sensor Flow Sensor Pressure Transducer Airflow Sensor (PTAF) Pro-Flow and Pro-Flow Plus Cannula Sensors PTAF 2, 3, Lite Sidestream Plus Pediatric Mask Sidestream Plus Adult Mask Sidestream Plus Nebulizer DirectView Data Management System Cough Assist T70 Trilogy 100 Ventilator BT, U.S. Trilogy EC Ventilator Garbin Ventilator BT Trilogy 100 BT International Trilogy 100 Ventilator Trilogy Nurse Call Adaptor Cable PLM Sensor ProChamber Valved Holding Chamber TrueBlue Nasal Mask Pico SE Nasal Mask Masimo MS Series Total Face Mask Heated Humidifier - HC100 AF541 EE Leak 1 Full Face Mask AF541 EE Leak 2 Full Face Mask AP111 EE/SE Nasal Mask Contour Deluxe/Comfort/Ptrak Nasal Mask SIDESTREAM TUCKER THE TURTLE MASK, SYSTEM 22 PAEDIATRIC MASK Alice NightOne Thermistor Cannula Style Personal Best Low Range Peak Flow Meter Chest Shell and components DirectView Data Management System A30 Heated Humidifier Universal Battery Pack (UBP2) BiPAP V30 Auto BiPAP A30 Ventilatory Support System REMstar Q-Series CPAP EncoreAnywhere BiPAP Q-Series PN841 Nasal Mask Wisp Pediatric Nasal Mask PN841 SE Nasal Mask Wisp Pediatric Nasal Mask SE Elbow Accessory 920 & 920M Handheld Pulse Oximeter Masimo Oximetry Kit REMStar SE CPAP Disposable/FEP/Invasive Circuits BiPAP Vision Sidestream Disposable Neb and Masks Passover Humidifier Opti Chamber Valved Holding Chamber SM Child Nasal Mask Vitalsense Bronchoscopy Elbow LiteTouch Mask Comfort Gel Blue Nasal Mask SimplyGo POC SimplyFlo POC SimplyGo Mini POC Nonin Wrist Ox REMstar Heated Humidifier Encore/Encore Pro Data Management System REMstar Plus CPAP OptiChamber Diamond with Lite Touch mask SnoreSilencer Performance Tubing Low Range Cabinet Flow Meter Oxygen Manifold Kit PLV-102 & 102b AF531 Oro-Nasal SE Face Mask Stardust 2 Stardust I, II Heated Humidifier - MR850 BiPAP autoSV Advanced BiPAP AVAPS or S/T C-Series EncoreAnywhere Innospire Essence Innospire Elegance Disposable 15 mm non-heated passive and heated active circuits Disposable 22mm non-heated passive and heated active circuits Disposable 15mm MPV circuit Pressure Valve Care Orchestrator Nonin Oximetry Kit ECG electrode REMstar/BiPAP Q-Series w/HT BiPAP Q-Series w/HT REMstar Q-series CPAP w/HT Drain, Tee (water trap) Respironics Disposable Heated Wire Circuits Disposable Adult/Ped Heated Active Circuit Disposable Adult/Ped Heated Passive Circuit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2012-12-18
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2010-08-05
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2010-10-14
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2015-09-09
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2011-01-20
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2007-12-21
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2017-07-31
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2015-01-27
MQM Bilirubin (Total And Unbound) In The Neonate Test System Clinical Chemistry Class 1 862.1113 2007-12-31
BWF Spirometer, Therapeutic (Incentive) Anesthesiology Class 2 868.5690 2007-12-07
MYB Pillow, Cervical (For Mild Sleep Apnea) Dental Class 2 872.5570 2019-04-16
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2020-09-14
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2020-09-14
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2010-08-10
DQA Oximeter Cardiovascular Class 2 870.2700 2011-03-01
CAE Airway, Oropharyngeal, Anesthesiology Anesthesiology Class 1 868.5110 2000-10-02
HCC Device, Biofeedback Neurology Class 2 882.5050 2018-04-16
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2022-12-20
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2007-12-31
GWQ Full-Montage Standard Electroencephalograph Neurology Class 2 882.1400 2007-12-31
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2015-11-09
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2016-08-03
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2010-06-09
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2010-08-05
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2013-04-26
FOX Stand, Infusion General Hospital Class 1 880.6990 2019-10-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2012-11-07
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2009-12-11
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2007-12-21
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-04-12
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2024-09-30
BTK Strap, Head, Gas Mask Anesthesiology Class 1 868.5560 1992-07-08
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2007-12-31
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2010-08-03
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2019-08-23
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2019-08-23
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2012-08-14
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2006-09-12
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2022-01-11
OUG Medical Device Data System General Hospital Class 1 880.6310 2011-10-25
BZC Calculator, Pulmonary Function Data Anesthesiology Class 2 868.1880 2007-12-18
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2007-12-21
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2007-12-07
NHJ Device, Positive Pressure Breathing, Intermittent Anesthesiology Class 2 868.5905 2013-01-08
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2010-06-09
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2007-12-21
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2004-11-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-06-10
DQA Oximeter Cardiovascular Class 2 870.2700 2011-03-01
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2007-12-31
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2011-01-20
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2017-09-13
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2007-12-31
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2017-06-19
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2015-03-26
BZQ Monitor, Breathing Frequency Anesthesiology Class 2 868.2375 2007-12-21
BZH Meter, Peak Flow, Spirometry Anesthesiology Class 2 868.1860 2007-12-07
BYT Ventilator, External Body, Negative Pressure, Adult (Cuirass) Anesthesiology Class 2 868.5935 2008-12-22
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2012-02-13
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2010-01-14
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-05-23
DQA Oximeter Cardiovascular Class 2 870.2700 2017-02-28
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2011-11-17
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2011-11-17
DQA Oximeter Cardiovascular Class 2 870.2700 2011-11-17
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2016-06-29
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2007-12-31
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 1999-11-01
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2007-12-31
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2007-12-07
BYE Attachment, Breathing, Positive End Expiratory Pressure Anesthesiology Class 2 868.5965 2009-12-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2007-12-19
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2018-08-07
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2010-07-14
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2010-08-02
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2012-01-17
DQA Oximeter Cardiovascular Class 2 870.2700 2011-03-01
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2007-12-31
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2007-12-31
NVP Holding Chambers, Direct Patient Interface Anesthesiology Class 2 868.5630 2011-09-15
LRK Device, Anti-Snoring Dental Class 2 872.5570 2010-03-23
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2000-07-18
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2008-12-22
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2025-01-03
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2007-12-31
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2011-01-20
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2010-08-05
BTI Compressor, Air, Portable Anesthesiology Class 2 868.6250 2007-12-07
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2007-12-07
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2019-10-09
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2007-12-31
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2024-10-31
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-10-31
NOU Continuous, Ventilator, Home Use Anesthesiology Class 2 868.5895 2024-10-31
OLZ Automatic Event Detection Software For Polysomnograph With Electroencephalograph Neurology Class 2 882.1400 2024-10-31
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2024-10-31
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2024-10-31
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2024-10-31
MNR Ventilatory Effort Recorder Anesthesiology Class 2 868.2375 2024-10-31
MNS Ventilator, Continuous, Non-Life-Supporting Anesthesiology Class 2 868.5895 2011-11-17
DRX Electrode, Electrocardiograph Cardiovascular Class 2 870.2360 2009-11-10
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2012-01-17
BYH Drain, Tee (Water Trap) Anesthesiology Class 1 868.5995 2000-10-02
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2011-07-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3038281851 Philips Polska Sp. z o.o. Lodz Lodzkie, PL
3003584029 Braemar Manufacturing, LLC San Diego, CA, US
3042175841 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Best Noord-Brabant, NL
3008514395 Telcare, LLC Linwood, PA, US
3004961434 RESPIRATORY TECHNOLOGIES, INC. Plymouth, MN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033276 Resmed, Ltd. VPAP III ST-A 2004-06-07
K923989 Sensor Medics Corp. SENSORMEDICS MODEL 6200 AUTOBOX DL 1993-08-09
K012633 Respironics, Inc. RESPIRONICS HEATED HUMIDIFIER 2002-02-28
K970478 Marquest Medical Products, Inc. SCT 3000 HEATED HUMIDIFIER 1997-07-16
K792722 Novametrix Medical Systems, Inc. NOVAMETRIX CPAP NASAL CANNULA 1980-01-24

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2015 Respironics California Inc 2
Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0009-2020 TELEFLEX-MORRISVILLE 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020 Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan 2
Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518422. Last updated year: 2026. Please use registration number 2518422 when referencing this establishment in official correspondence.
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