FISHER & PAYKEL HEALTHCARE, LTD.

FDA Device Registration & Listing · EAST TAMAKI Auckland, NZ · Registration 9611451

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
9611451
FEI Number
3002806988
Entity Name
FISHER & PAYKEL HEALTHCARE, LTD.
City/State/Country
EAST TAMAKI Auckland, NZ
Establishment Address
15 MAURICE PAYKEL PLACE, EAST TAMAKI Auckland 2013, NZ
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
FISHER & PAYKEL HEALTHCARE NZ LTD (Owner Number: 8040217)
Owner / Operator Contact Address
15 MAURICE PAYKEL PLACE, EAST TAMAKI, AUCKLAND, NZ-NOTA 2013, NZ
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K040366
PMA Number
N/A

All Registered Proprietary Names

OptiNIV OptiPAP Junior Propre Waterfeed set Mobile pole stand Dual cylinder rack Cable/Hose Hook Mounting bracket for bird blender, includes CosyCot mounting block Compact Stand Accessory hook Humidifier Mounting Tray Side Mounting Block: Infant Resuscitator wall mount bracket Quad Hook Side Shelf and Support Block mounting bracket Pole Mounting Tray Suction canister mounting block Mounting pole long UPS Mounting Kit Single cylinder rack large Pole mounting tray Mounting pole short Dovetail Channel Rail Bracket Bird blender pole mount bracket Infusion stands Dovetail Rail (AA502) DIN Rail (AA501) Mounting Humidifier Pole (AA503) Airvo Nebulizer Adapter Evaqua Servo Wall Mount Infant Warmer Wall mount bracket Manual Wall Mount Infant Warmer Wall Mount Infant Warmer F&P Optiflow Oxygen Kit 900HC451 Oracle Opus Nasal Pillows Mask HC482 Opus Nasal Pillows Zest Petite Lady Zest Q Headgear - Rose Zest Q Zest Petite Nasal Mask Air entrainer neoweigh Infant Scales Trache direct connection Airway connectors 400475 F&P Simplus Full Face Mask - Small F&P Simplus Full Face Mask 400476 F&P Simplus Full Face Mask - Medium 400477 F&P Simplus Full Face Mask - Large F&P Simplus Full Face Mask SL - Small F&P Simplus Full Face Mask SL - Large F&P Simplus Full Face Mask SL - Medium 400483FITPACK SIMPLUS Full Face Mask Fit Pack SML SIMPLUS Full Face Mask Fit Pack SML neoBLUEmini LED Phototherapy System IW980JEU Wall Mount Warmer Baby IW990JEU Wall Mount Warmer Manual Oxygen/Pressure Port Connector Oracle 452 HC451 Oracle F&P Optiflow Flow Diverter 400421SL F&P Pilairo Q Nasal Pillows Mask - SL F&P Pilairo Q Diffuser & Cover 400421 F&P Pilairo Q Nasal Pillows Mask Pilairo Pilairo Nasal Pillows Mask Zest Q Zest Plus Zest Zest Q Plus Zest Nasal Mask Tee drains (water traps) Airvo 3 RT045XS/S/M/L RT055XS/S/M/L Airvo 2 Series Humidifier PT101US Airvo 2 Humidifier myAIRVO 2 HUMIDIFIER Chamber Reusable for HC600 Series HEATED BREATHING TUBE AND CHAMBER KIT HEATED BREATHING TUBE PT100US myAirvo 2 Humidifier Tube and Chamber Kit (Junior) Disinfection kit WATERBAG AIRVO 2 HUMIDIFIER AUTOFEED CHAMBER Smartstick Auto CPAP Humidifier Performance Maximiser CPAP Humidifier HC254 Sleepstyle 200 Auto AIRVO Humidifier myAIRVO Humidifier Eson Mask F&P Eson Nasal Mask HumiGard Chamber Reuseable ThermoSmart Water Chamber for Humidified CPAP HC600 Series CPAP Humidifier MR730 Respiratory Humidifier Tube Bonnet BC3020-10 Chin Strap Mask interface adaptor Head Gear Chamber Connector ADAPTOR KITS MIDLINE PATIENT INTERFACE 850 AirSpiral Adult NIV and NHF Circuit Kit Face Mask Non Vented Fisher & Paykel Healthcare 850 Respiratory Humidifier RT020 End Expiratory Filter Paediatric analog vacuum Paediatric digital vacuum Venturi Backpack Suction Assembly Amvex Vacuum Regulator Digi/Analg Amvex Venturi backpack suction MR290 Humidification Chamber Breathing tube supports RT280, 'Adult Evaqua 2' Dual Heated Breathing Circuit RT302 MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow+ Nasal Cannula RT332, 'MicroCell Technology Heated Inspiratory Adult Breathing Circuit and Optiflow Nasal Cannula' RT232, 'Adult Optiflow Circuit Kit with MicroCell Technology RT481 Care Continuum Kit- Vent Use RT380 and RT385, 'Adult Evaqua 2' Dual Heated Breathing Circuits Infant Evaqua 2 (RT265/RT266) FlexiFit 407 (Sleep Lab) FlexiFit 407 FlexiFit 405 (Sleep Lab) Mask Oxygen NeoWrap Occlusive Wrap 25x NeoWrap Occlusive Wrap 10x NeoWrap Polyethylene Occlusive Wrap Starter Kit NeoWrap FPH Bubble CPAP System FlexiFit Series HC431 Flexifit Full Face Mask Vitera Mask Dbl Seal Sml/Sml A Model Vitera Mask Full Face Small Sleep Lab Vitera Mask Full Face Large Sleep Lab Vitera Mask Dbl Seal Med/Med A Model Vitera Mask Full Face Medium A Model Vitera Mask Dbl Seal Lrg/Lrg A Model Vitera Mask Fitpack Sml/Med/Lrg A Model Vitera Mask Full Face Small A Model Vitera Mask Full Face Medium Sleep Lab Vitera Mask Full Face Med/Lrg Sleep Lab Vitera Mask myStart Pack Sml/Med/Lrg A Model Vitera Mask Full Face Large A Model Optiflow Air/Oxygen Flow Source Optiflow myAirvo 3 F&P 950 Respiratory Humidifier F&P 950 MR410 Respiratory Humidifier NS232 Nerve Locator NS272 Nerve Locator and Stimulator DaisyDot Sensor Cover DaisyDot Mini Sensor Cover Optiflow Junior 2 WigglewiNG XS S Optiflow Junior 2 WigglewiNG XXL Optiflow Junior 2 WigglewiNG M L XL Suction accessory block Gas accessory block Gas supply module Gas low pressure module Neopuff Supply Line-Short Flowmeter Neopuff Supply Line-Long Amvex gas hoses F&P Brevida™ Nasal Pillows Mask Infosmart Software package MR850 Resipiratory Humidifier F&P Nova Nasal Nasal cannula large Nasal cannula small Nasal cannula medium Optiflow+ nasal cannula Nasal cannula extra large Nasal cannula extra small RT oxygen cannula Optiflow oxygen cannula BC oxygen cannula COSYCOT WARMER IW931JEU IW932JEU IW933JEU IW934JEU IW951JEU IW952JEU IW953JEU IW954JEU Pressure Gauge InfoGSM InfoSmart Web OJR215 Pressure Relief Manifold Oxygen Flowmeter Nipple - Green(900IW119G) Amvex flowmeters Optiflow Oxygen Kit MR850 Respiratory Humidifier Airvo 3 NIV HC500 Respiratory Humidifier F&P SleepStyle Auto CPAP, F&P SleepStyle CPAP, Thermosmart Breathing Tube, Standard Breathing Tube, Water Chamber F&P Nova Micro PIllows Mask F&P Nova Micro Pressure Manifold

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2025-11-30
SGR Noninvasive Positive Airway Pressure System, Facility Use Anesthesiology Class 2 868.5895 2025-11-30
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2016-04-13
CAW Generator, Oxygen, Portable Anesthesiology Class 2 868.5440 2008-07-10
FOX Stand, Infusion General Hospital Class 1 880.6990 2009-01-20
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2022-01-13
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2008-01-29
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2007-12-02
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-08-29
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-04-18
BZR Mixer, Breathing Gases, Anesthesia Inhalation Anesthesiology Class 2 868.5330 2007-11-28
FRW Scale, Patient General Hospital Class 1 880.2720 2008-01-23
BZA Connector, Airway (Extension) Anesthesiology Class 1 868.5810 2009-01-20
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2013-06-12
LBI Unit, Neonatal Phototherapy General Hospital Class 2 880.5700 2008-02-12
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2007-12-02
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-18
CBP Valve, Non-Rebreathing Anesthesiology Class 2 868.5870 2024-08-29
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2012-04-03
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2009-05-25
BYH Drain, Tee (Water Trap) Anesthesiology Class 1 868.5995 2009-01-20
QAV High Flow/High Velocity Humidified Oxygen Delivery Device Anesthesiology Class 2 868.5454 2023-02-14
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2017-09-03
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2013-10-31
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-09-14
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2010-02-10
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2012-10-09
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2017-07-17
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-18
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2008-01-30
BZO Set, Tubing And Support, Ventilator (W Harness) Anesthesiology Class 1 868.5975 2002-07-29
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2022-04-25
CBK Ventilator, Continuous, Facility Use Anesthesiology Class 2 868.5895 2009-03-25
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-08-25
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2007-11-28
KDP Regulator, Vacuum General Hospital Class 2 880.6740 2008-08-19
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2008-01-29
JAY Support, Breathing Tube Anesthesiology Class 1 868.5280 2009-01-20
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2012-12-18
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer Anesthesiology Class 2 868.5270 2012-08-09
BYG Mask, Oxygen Anesthesiology Class 1 868.5580 2001-06-25
KME Bedding, Disposable, Medical General Hospital Class 1 880.6060 2004-05-21
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2010-11-22
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2008-02-18
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2019-10-14
BZR Mixer, Breathing Gases, Anesthesia Inhalation Anesthesiology Class 2 868.5330 2025-09-10
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2024-08-28
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2023-06-26
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2008-01-30
KOI Stimulator, Nerve, Peripheral, Electric Anesthesiology Class 2 868.2775 2007-11-28
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2009-08-04
BYX Tubing, Pressure And Accessories Anesthesiology Class 1 868.5860 2009-01-20
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2017-01-18
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2008-01-29
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2026-02-09
CAT Cannula, Nasal, Oxygen Anesthesiology Class 1 868.5340 2005-08-22
FMT Warmer, Infant Radiant General Hospital Class 2 880.5130 2007-11-28
BXH Gauge, Gas Pressure, Cylinder/Pipeline Anesthesiology Class 1 868.2610 2009-01-27
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2011-08-29
CBP Valve, Non-Rebreathing Anesthesiology Class 2 868.5870 2019-05-02
CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated Anesthesiology Class 1 868.2340 2009-01-21
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2022-04-25
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2008-01-29
MNT Sv70 Ventilator Anesthesiology Class 2 868.5895 2024-08-29
BTT Humidifier, Respiratory Gas, (Direct Patient Interface) Anesthesiology Class 2 868.5450 2008-01-29
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2018-11-11
BZD Ventilator, Non-Continuous (Respirator) Anesthesiology Class 2 868.5905 2024-08-25
CBP Valve, Non-Rebreathing Anesthesiology Class 2 868.5870 2007-11-28

Official Correspondent

Brian Schultz

US Agent Details

Diego Vargas Banuelos Business: FISHER & PAYKEL LIMITED HEALTHCARE Email: Diego.VargasBanuelos@fphcare.com Phone: (949) 4341005

Related Public Records

Same Entity

FISHER & PAYKEL HEALTHCARE NZ LTD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3015928685 FISHER & PAYKEL HEALTHCARE S.A.DE C.V. Tijuana, Baja California, MX
3008264065 Fisher & Paykel Healthcare S.A.de C.V. Tijuana Baja California, MX
2085602 FISHER & PAYKEL HEALTHCARE, INC. IRVINE, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K012633 Respironics, Inc. RESPIRONICS HEATED HUMIDIFIER 2002-02-28
K970478 Marquest Medical Products, Inc. SCT 3000 HEATED HUMIDIFIER 1997-07-16
K003939 Invacare Corp. VENTURE HOME FILL II, MODEL IOH 200 2001-03-21

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611451. Last updated year: 2026. Please use registration number 9611451 when referencing this establishment in official correspondence.
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