Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2085602

FEI Number

3000210616

Entity Name

FISHER & PAYKEL HEALTHCARE, INC.

City/State/Country

IRVINE, CA, US

Establishment Address

17400 Laguna Canyon Road, #300, IRVINE, CA 92618, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IW910JEU MOBILE WARMER BABY W920JEU MOBILE WARMER MANUAL myAirvo Optiflow 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 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 F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility Eson Mask F&P Eson Nasal Mask Zest Petite Lady Zest Q Headgear - Rose Zest Q Zest Petite Nasal Mask Zest Nasal Mask HumiGard F&P Nova Micro PIllows Mask F&P Nova Micro NS232 Nerve Locator NS272 Nerve Locator and Stimulator MR850 Respiratory Humidifier Evaqua F&P 950 Respiratory Humidifier F&P 950 F&P Solo Mask Range Paediatric analog vacuum Paediatric digital vacuum Venturi Backpack Suction Assembly Amvex Vacuum Regulator Digi/Analg Amvex Venturi backpack suction 400473SL Forma Full Face Mask 400473A Forma Full Face Mask HC432 Flexifit Full Face Mask 400471A Forma Full Face Mask 400470A Forma Full Face Mask 400470SL Forma Full Face Mask 400471SL Forma Full Face Mask Fisher & Paykel Healthcare 850 Respiratory Humidifier InfoGSM InfoSmart Web HC451 Oracle Oxygen/Pressure Port Connector Oracle 452 HC451 Oracle Oxygen Flowmeter Nipple - Green(900IW119G) Amvex flowmeters FPH Bubble CPAP System 900MR810 Adult Single Limb Circuit MR810 Respiratory Humidifier Propre Infosmart Software package MR850 Resipiratory Humidifier MR410 Respiratory Humidifier Icon Heated Breathing Tube Infosmart Software package ICON+ Novo CPAP ICON+ Auto CPAP 900ICON208 ThermoSmart Breathing Tube InfoUSB2 Infosmart CD Oxygen Elbow SmartStick Net Icon Chamber ICON+ Premo CPAP Airvo 3 NIV 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) Optiflow Luer Tee Optiflow 3S Nasal Cannula MR290 Humidification Chamber NeoWrap Occlusive Wrap 25x NeoWrap Occlusive Wrap 10x NeoWrap Polyethylene Occlusive Wrap Starter Kit NeoWrap Bird Gas Blender OptiPAP Junior RT045XS/S/M/L RT055XS/S/M/L F&P Eson 2 ESON2 Nasal Mask Fit Pack ESN2SML ESON2 Nasal Mask Fit Pack Optiflow Oxygen Kit Breathing tube supports neoBLUEmini LED Phototherapy System myAirvo 3 RT020 End Expiratory Filter F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling Optiflow Trace F&P Evora Nasal Mask F&P Optiflow Oxygen Kit Opus Nasal Pillows Mask HC482 Opus Nasal Pillows HC550 Humidifier (HC550JHU) 900RT008 AIR ENTRAINER OptiNIV AirSpiral Heated Breathing Tube Optiflow Patient Interface F&P Optiflow Flow Diverter Tee drains (water traps) HC500 Respiratory Humidifier Airvo Series Humidifier Heated breathing tube Airvo disinfection kit Waterbag Airvo 2 (Junior tube and chamber) Autofeed Chamber Heated breathing tube and chamber PT100US myAirvo 2 Humidifier PT101US Airvo 2 Humidifier Optiflow Air/Oxygen Flow Source Optiflow 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 Inspiratory/Expiratory Filter Bio-Med Inc. air/oxygen blender BC506-01 MR850 Respiratory Humidifier F&P Evora Full Mask MR850 + Smart Adaptor Sleepstyle 200 Series CPAP Humidifier COSYCOT WARMER IW931JEU IW932JEU IW933JEU IW934JEU IW951JEU IW952JEU IW953JEU IW954JEU Resuscitation T-Piece Kit: Humidified resuscitation system Resuscitation T-Piece Kit: Single use T-Piece-Classic with Mask 60mm Resuscitation T-Piece Kit: Single use T-Piece-Classic with Mask 50mm Resuscitation T-Piece Kit: Single use T-Piece Circuit-Classic Neopuff T-piece infant resuscitator Resuscitation T-Piece Kit: Single use T-Piece-Classic F&P 950 Bubble CPAP Breathing Circuit Kits AIRVO Humidifier myAIRVO Humidifier OJR215 Pressure Relief Manifold 900HC451 Oracle Optiflow Switch+ Optiflow Switch+ Servo Wall Mount Infant Warmer Wall mount bracket Manual Wall Mount Infant Warmer Wall Mount Infant Warmer Anesthesia breathing circuits F&P SleepStyle Auto CPAP, F&P SleepStyle CPAP, Thermosmart Breathing Tube, Standard Breathing Tube, Water Chamber RT046XS/S/M/L RT056XS/S/M/L FlexiFit 407 (Sleep Lab) FlexiFit 407 FlexiFit 405 (Sleep Lab) Mask Oxygen RT043S, RT043M, RT043L (Single Use - Hospital Full Face Masks) RT040S, RT040M, RT040L Smartstick Auto CPAP Humidifier Performance Maximiser CPAP Humidifier HC254 Sleepstyle 200 Auto FlexiFit Series HC431 Flexifit Full Face Mask Waterfeed set F&P Nova Nasal Pressure Manifold F&P 820 Humidification System NS242 Peripheral Nerve Stimulator Optiflow Junior 2/2+ Interface Range NS252 Nerve Stimulator IW980JEU Wall Mount Warmer Baby IW990JEU Wall Mount Warmer Manual 900ICON203 InfoUSB2 INFOUSB_METRO InfoUSB INFOUSB_2 InfoUSB2 INFOUSB_MAC InfoUSB2 InfoUSB software Chamber Reuseable ThermoSmart Water Chamber for Humidified CPAP HC600 Series CPAP Humidifier Pressure Gauge

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2007-11-28
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2025-09-10
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2005-08-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2009-08-04
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	2012-10-09
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2011-04-18
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-09-14
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2017-07-17
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2024-08-25
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2007-11-28
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-01-29
BZE	Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	Anesthesiology	Class 2	868.5270	2008-01-29
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2023-06-26
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2023-05-30
KDP	Regulator, Vacuum	General Hospital	Class 2	880.6740	2008-08-19
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	2024-08-25
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2011-08-29
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
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2009-01-21
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-11-22
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2014-06-05
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2016-04-13
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-01-29
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-01-30
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-04-28
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2024-08-29
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2009-01-20
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2020-04-08
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-01-29
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2004-05-21
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2009-02-16
SGR	Noninvasive Positive Airway Pressure System, Facility Use	Anesthesiology	Class 2	868.5895	2025-11-30
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2017-09-03
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2016-09-20
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2022-04-25
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2009-01-20
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2008-02-12
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-08-28
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2007-11-28
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2021-04-20
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2020-06-02
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
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2014-10-30
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	1995-08-31
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2025-11-30
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2018-12-20
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2024-08-29
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2009-01-20
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-01-29
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2013-01-16
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2025-09-10
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2019-10-14
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2008-01-29
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	Class 2	868.5330	2008-11-03
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	2022-03-20
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2008-04-10
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2007-11-25
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2007-11-28
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2007-12-02
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2023-10-19
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2010-02-10
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2019-05-02
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	2026-02-10
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2007-12-02
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2009-01-20
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2018-11-11
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2018-01-29
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2001-06-25
MNT	Sv70 Ventilator	Anesthesiology	Class 2	868.5895	2006-05-02
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-09-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-02-18
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2008-07-10
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2026-02-09
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-11-28
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2024-03-25
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	Class 2	868.2775	2008-02-11
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2023-04-18
BXN	Stimulator, Nerve, Battery-Powered	Anesthesiology	Class 2	868.2775	2007-11-28
FMT	Warmer, Infant Radiant	General Hospital	Class 2	880.5130	2007-12-02
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2012-07-16
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2008-02-18
BXH	Gauge, Gas Pressure, Cylinder/Pipeline	Anesthesiology	Class 1	868.2610	2009-01-27

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
3008264065	Fisher & Paykel Healthcare S.A.de C.V.	Tijuana Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020219	Replacement Parts Industries, Inc.	RPI SKIN OR AIR TEMPERATURE PROBE	2002-04-12
K881713	Gempco, Inc.	SPECIAL PROCEDURES BASE UNIT MODEL 500	1988-07-12
K012633	Respironics, Inc.	RESPIRONICS HEATED HUMIDIFIER	2002-02-28
K970478	Marquest Medical Products, Inc.	SCT 3000 HEATED HUMIDIFIER	1997-07-16
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2085602. Last updated year: 2026. Please use registration number 2085602 when referencing this establishment in official correspondence.