Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002797442

FEI Number

3002797442

Entity Name

RESPIRONICS, INC.

City/State/Country

Mount Pleasant, PA, US

Establishment Address

174 Tech Center Drive, Mount Pleasant, PA 15666, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Philips Medical Systems International BV (Owner Number: 2518422)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092835

PMA Number

N/A

All Registered Proprietary Names

Sidestream Disposable Neb and Masks Threshold Pep DirectView Data Management System Encore Anywhere A40 Heated Humidifier OMNILAB DIRECT Universal Battery Pack (UBP2) BiPAP A40 Ventilatory Support System Universal Battery Pack (UBP2) Trilogy 202 Ventilator Trilogy Nurse Call Adaptor Cable Innospire Essence Innospire Elegance ProChamber Valved Holding Chamber REMstar Heated Humidifier Encore/Encore Pro Data Management System REMstar Plus CPAP OptiChamber Diamond with Lite Touch mask Sidestream Plus Pediatric Mask Sidestream Plus Adult Mask Sidestream Plus Nebulizer Alice PDX 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 DreamWear Full Mask DreamWear Nasal Mask DreamWisp Nasal Mask Pressure Transducer Airflow Sensor (PTAF) Pro-Flow and Pro-Flow Plus Cannula Sensors PTAF 2, 3, Lite Innospire Mini Wisp Youth Nasal Mask Threshold IMT 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 Sleepware G3 Sleepware Alice 6 PSG Base Station LDE LDxN LDxS Alice 6 Headbox LDE LDx Alice PSG or components ECG wireset Nuance and Nuance Pro Nasal Pillow Mask Amara View FFM - RIMR, RIMP ComfortFull FFM - RSZ Amara FFM - RIMR, RIMP Sidestream Reusable Neb and Masks Therapy Mask 3100 NC/SP REMstar/BiPAP Q-Series w/HT BiPAP Q-Series w/HT REMstar Q-series CPAP w/HT BiPAP autoSV Advanced BiPAP AVAPS or S/T C-Series EncoreAnywhere Disposable 15 mm non-heated passive and heated active circuits Disposable 22mm non-heated passive and heated active circuits Disposable 15mm MPV circuit Opti Chamber Valved Holding Chamber Stardust 2 Stardust I, II Respironics Disposable Heated Wire Circuits Disposable Adult/Ped Heated Active Circuit Disposable Adult/Ped Heated Passive Circuit Wisp Nasal Mask Wisp SE Nasal Mask 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 Comfort Gel Blue Nasal Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	1999-11-01
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-12-07
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2012-12-18
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2010-06-09
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
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2004-11-09
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
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-07
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2010-08-10
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2010-08-05
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-03-06
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2007-12-21
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2009-02-19
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-06-17
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2007-09-14
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
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2007-12-31
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2007-12-31
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2013-04-26
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-08-03
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	1999-11-01
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2021-07-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-01-17
MNS	Ventilator, Continuous, Non-Life-Supporting	Anesthesiology	Class 2	868.5895	2010-08-05
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2019-10-09
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-12-07
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2007-12-31
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2011-07-19
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2012-11-07
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2015-01-27
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-08-02

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
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K900686	Medical Industries America, Inc.	MAXI COMPRESSORS	1990-04-26

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-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Similar Registrations

Registration Number	Establishment Name	Location
1110315	MYLAN PHARMACEUTICALS INC.	Morgantown, WV, US
3018783526	CEVA LOGISTICS NETHERLANDS BV (Venray)	Oostrum Limburgh, NL
3005998497	SUNMED AP, LTD.	ZHUHAI Guangdong, CN
3006852037	Omron Healthcare Manufacturing Vietnam Co., Ltd.	Ho Chi Minh City, VN
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002797442. Last updated year: 2026. Please use registration number 3002797442 when referencing this establishment in official correspondence.