Data / Medical devices / New Zealand / Fisher & Paykel Healthcare, Ltd.

Fisher & Paykel Healthcare, Ltd.: FDA-registered device maker in EAST TAMAKI Auckland, New Zealand, 96 510(k) clearances

Name: Fisher & Paykel Healthcare, Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Fisher & Paykel Healthcare, Ltd. is registered with the FDA (registration 9611451) in EAST TAMAKI Auckland, New Zealand. It lists 36 device types. The FDA files 96 510(k) clearances under its listings, the newest dated August 27, 2026. 8 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 3, 2026.

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Get makers like this one Watch Fisher & Paykel Healthcare, Ltd.

FDA registration number: 9611451
FEI number: 3002806988
Address: 15 Maurice Paykel Place, EAST TAMAKI Auckland, New Zealand, 2013
Owner or operator: FISHER & PAYKEL HEALTHCARE NZ LTD (8040217)
Roles: Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler, Specification developer
First device listed: August 31, 1995
Registered through: 2027
Brand names listed: (Single Use - Hospital Full Face Masks), 400421 F&P Pilairo Q Nasal Pillows Mask, 400421SL F&P Pilairo Q Nasal Pillows Mask - SL, 400470A Forma Full Face Mask, 400470SL Forma Full Face Mask, 400471A Forma Full Face Mask, 400471SL Forma Full Face Mask, 400473A Forma Full Face Mask and more

Devices it lists

Device	Product code	Class	Role	Source
Bedding, Disposable, Medical	KME	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Continuous, Minimal Ventilatory Support, Facility Use Ventilator	MNT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Drain, Tee (Water Trap)	BYH	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Flowmeter, Tube, Thorpe, Back-Pressure Compensated	CAX	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Gauge, Gas Pressure, Cylinder/Pipeline	BXH	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Generator, Oxygen, Portable	CAW	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	BZE	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
High Flow/High Velocity Humidified Oxygen Delivery Device	QAV	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Insufflator, Laparoscopic	HIF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mask, Oxygen, Low Concentration, Venturi	BYF	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mixer, Breathing Gases, Anesthesia Inhalation	BZR	2	Complaint file establishment, Exporter to the US, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Noninvasive Positive Airway Pressure System, Facility Use	SGR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Regulator, Pressure, Gas Cylinder	CAN	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Regulator, Vacuum	KDP	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Scale, Patient	FRW	1	Complaint file establishment, Repackager or relabeler	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stand, Infusion	FOX	1	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Stimulator, Nerve, Battery-Powered	BXN	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Peripheral, Electric	KOI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Support, Breathing Tube	JAY	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tubing, Pressure And Accessories	BYX	1	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Unit, Neonatal Phototherapy	LBI	2	Complaint file establishment, Exporter to the US	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)	BTL	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Ventilator, Non-Continuous (Respirator)	BZD	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Warmer, Infant Radiant	FMT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 27, 2026	K262268	Optiflow Oxygen Kit (AA484J)	BTT	Substantially Equivalent	Fisher and Paykel Healthcare Limited	accessdata.fda.gov
December 19, 2025	K253479	Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
November 19, 2025	K250651	OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun	SGR	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
September 10, 2025	K252173	F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full	CBK	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
July 14, 2025	K243917	F&P Optiflow Air/Oxygen Flow Source	BZR	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 25, 2025	K251611	Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 18, 2025	K243583	F&P Nova Nasal Mask	BZD	Substantially Equivalent	Fisher & Paykel Healthcare Limited	accessdata.fda.gov
August 23, 2024	K233829	Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)	BZD	Substantially Equivalent	Fisher and Paykel Healthcare Limited	accessdata.fda.gov
August 9, 2024	K234053	F&P Optiflow Flow Diverter	CBP	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
August 9, 2024	K233643	F&P Airvo 3 NIV (PT311US)	MNT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
August 8, 2024	K234058	F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 13, 2024	K233821	F&P Optiflow Oxygen Kit (AA451J)	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
May 8, 2024	K222292	F&P myAirvo 3	BTT	Substantially Equivalent	Fisher & Paykel Healthcare	accessdata.fda.gov
February 7, 2024	K231956	F&P Optiflow+ Duet Nasal Cannula	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
September 5, 2023	K223684	F&P 820 Humidification System	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 29, 2023	K221436	F&P 950 Accessory Breathing Circuit Kits	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 16, 2023	K220703	F&P 950 Respiratory Humidifier	BTT	Substantially Equivalent	Fisher & Paykel Healthcare	accessdata.fda.gov
May 17, 2023	K223696	F&P Solo Mask Range	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
April 6, 2023	K222197	F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
January 27, 2023	K221338	F&P Airvo 3	QAV	Substantially Equivalent	Fisher & Paykel Healthcare	accessdata.fda.gov
April 22, 2022	K212031	F&P 850 AirSpiral Adult NIV and NHF Circuit Kit	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 18, 2022	K212371	F&P Evora Full Face Mask	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
January 28, 2022	K211096	Optiflow Oxygen Kit	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
December 10, 2021	K211560	Airvo Nebulizer Adapter	CAF	Substantially Equivalent	Fisher & Paykel Healthcare Limited	accessdata.fda.gov
April 14, 2021	K203449	F&P Visairo NIV Mask Range	CBK	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 16, 2021	K201723	F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 2, 2020	K200089	F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 19, 2020	K191818	F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 9, 2020	K191624	F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version	MNT	Substantially Equivalent	Fisher & Paykel Healthcare Limited	accessdata.fda.gov
October 11, 2019	K190713	F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
April 5, 2019	K173770	OJR215 Pressure Relief Manifold	CBP	Substantially Equivalent	Fisher & Paykel Healthcare Limited	accessdata.fda.gov
December 20, 2018	K162553	AirSpiral Heated Breathing Tube	BTT	Substantially Equivalent	Fisher & Paykel Healthcare	accessdata.fda.gov
August 8, 2018	K173193	F&P SleepStyle	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
January 25, 2018	K173060	F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version	CBK	Substantially Equivalent	Fisher and Paykel Healthcare Limited	accessdata.fda.gov
August 24, 2017	K170367	Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Large, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Medium, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Small, Nivairo RT045 Non-Vented Hospital Full Face Mask Anti-Asphyxiation Valve - Extra Small	MNT	Substantially Equivalent	Fisher and Paykel Healthcare Limited	accessdata.fda.gov
June 23, 2017	K162582	HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit	HIF	Substantially Equivalent	Fisher & Paykel Healthcare	accessdata.fda.gov
January 18, 2017	K161412	F&P Brevida Nasal Pillows Mask	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
September 20, 2016	K153505	F&P Eson 2 Nasal Mask	BZD	Substantially Equivalent	Fisher & Paykel Healthcare Limited	accessdata.fda.gov
March 5, 2015	K143646	MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 25, 2014	K132017	HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
February 5, 2014	K133666	RT016 INSPIRATORY FILTER	CAH	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
December 4, 2013	K131957	MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
October 24, 2013	K131895	AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 5, 2013	K130328	F&P SIMPLUS FULL FACE MASK	BZD	Substantially Equivalent	Fisher & Paykel Healthcare Limited	accessdata.fda.gov
January 3, 2013	K121975	AIRVO HUMIDIFIER MYAIRO HUMIDIFIER	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
December 6, 2012	K122432	ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS	BZE	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
October 2, 2012	K121597	ESON NASAL MASK	BZD	Substantially Equivalent	Fisher & Paykel Healthcare Limited	accessdata.fda.gov
April 16, 2012	K103767	DUAL HEATED INFANT VREATHING CIROUITS	BZE	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 30, 2012	K110019	RESPIRATORY HUMIDIFER	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
February 23, 2012	K120027	PILAIRO NASAL PILLOWS MASK	BZD	Substantially Equivalent	Fisher & Paykel Healthcare Limited	accessdata.fda.gov
August 19, 2011	K110316	INFOSEND GSM	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 24, 2011	K103786	ZEST PETITE NASAL MASK	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
October 8, 2010	K100011	FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
May 28, 2010	K100554	RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
April 27, 2010	K094040	F&P ICON SERIES CPAP	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
January 27, 2010	K092846	AIRVO SERIES HUMIDIFIERS	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 16, 2009	K083832	ZEST NASAL MASK	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 4, 2009	K083122	HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041	CBK	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
September 12, 2008	K081029	SLEEPSTYLE 200 AUTO SERIES HC254	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
September 12, 2008	K080209	FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 31, 2008	K073706	RESPIRATORY HUMIDIFIER, MODEL MR850	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
December 22, 2006	K063036	OPUS HC482 DIRECT NASAL MASK	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
August 29, 2006	K061236	FLEXIFIT HC432 FULL FACE MASK	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
April 6, 2006	K060044	ACUTE CARE FACE MASK, MODEL RT040	MNT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
August 1, 2005	K050927	RT019 INSPIRATORY/EXPIRATORY FILTER	CAH	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
May 25, 2005	K050904	CPAP HUMIDIFIER, MODEL HC238JHU	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
January 12, 2005	K034026	RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS	BZE	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
August 31, 2004	K041900	HC604 CPAP HUMIDIFIER	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 10, 2004	K040941	CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
May 5, 2004	K040506	FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
April 13, 2004	K033710	MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
March 4, 2004	K040366	PRESSURE MANIFOLD, MODEL BC 110	CBP	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
January 14, 2004	K033087	ORACLE ORAL MASK, MODEL HC451A	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
July 7, 2003	K020332	RESPIRATORY HUMIDIFIER, MODEL MR850	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 12, 2003	K023559	FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
September 19, 2002	K022196	NATUS BLUE LIGHT PHOTOTHERAPY UNIT	LBI	Substantially Equivalent	Natus Medical, Inc.	accessdata.fda.gov
October 4, 2001	K002839	END EXPIRATORY FILTER, MODEL RT020	CAH	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 25, 2001	K003894	ORACLE ORAL MASK	BZD	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
June 1, 2001	K003973	RESPIRATORY HUMIDIFIER, MODEL HC150	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
November 10, 1998	K983112	RESPIRATORY HUMIDIFIER, MODEL # MR850	BTT	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov
October 30, 1997	K972885	SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970	FMT	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
July 28, 1997	K971695	SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER	FMT	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
July 16, 1997	K971461	SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)	FMT	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
May 7, 1997	K970432	INFANT RADIANT WARMER - MODELS IW910 AND IW920	FMT	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
March 12, 1996	K953392	HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES)	BTT	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
November 8, 1995	K953711	AIR ENTRAINER 900RT008	BZR	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
October 16, 1995	K953949	HUMIDIFIER & ACCESSORIES	CAW	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
January 24, 1994	K934140	MR290 HUMIDIFICATION CHAMBER SINGLE USE	BTT	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
October 7, 1993	K925982	BMD AIR/OXYGEN BLENDER	BZR	Substantially Equivalent	Biomedical Devices, Inc.	accessdata.fda.gov
May 27, 1993	K924234	CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272	KOI	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
June 25, 1992	K913367	MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS	BTT	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
January 13, 1992	K913368	MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC	BTT	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
October 6, 1989	K892885	RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR	BTL	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
November 28, 1988	K883868	MODEL NS242 CONSTANT CURRENT PERIPHERAL NERVE STIM	BXN	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.	accessdata.fda.gov
November 16, 1988	K883038	P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER	BZR	Substantially Equivalent	Bird Products Corp.	accessdata.fda.gov
July 18, 1988	K882438	CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252	BXN	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 18, 2025	97591	Class II	Ongoing	Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723	When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible	accessdata.fda.gov
August 7, 2024	95173	Class II	Ongoing	PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infan	Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could lead to hypoxia.	accessdata.fda.gov
April 2, 2024	94398	Class II	Ongoing	Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US	Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.	accessdata.fda.gov
November 6, 2014	69668	Class II	Terminated	Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg	Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury.	accessdata.fda.gov
April 15, 2014	68011	Class I	Terminated	Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-	The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.	accessdata.fda.gov
April 22, 2013	49033	Class II	Terminated	Fisher & Paykel Healthcare ICON CPAP (continuous positive airway pressure). Models: ICON Auto: ICONAAN, ICONAAN-HT, ICONAAJ. ICON Novo: ICONNAN, ICONNAN-HT, ICONNAJ. ICON Premo: ICONPBN, ICONPBN-HT, ICONPBN-HTC. The ICON	Fisher and Paykel Healthcare is recalling the ICON CPAP units because there is a potential power issue on certain ICON CPAP. These ICON CPAP units could potentially become inoperable, which would result in a lack of treatment to the patient's obstructive sleep apnea symptoms until a replacement unit is obtained.	accessdata.fda.gov
November 19, 2012	63794	Class I	Terminated	Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.	FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which ma	accessdata.fda.gov
October 9, 2006	37003	Not yet classified	Terminated	Fisher & Paykel IW930 CosyCot Infant Radiant Warmer (with integrated bed) fitted with 9001W005J Elevator Module	This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in height. A bent pivot plate generally results in the Warmer being unable to elevate properly. Other component failures may	accessdata.fda.gov

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Updated August 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.