Fisher & Paykel Healthcare, Ltd.
Fisher & Paykel Healthcare, Ltd. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2025, with 7 FDA device recalls on record.
Top product codes for Fisher & Paykel Healthcare, Ltd.
FDA recalls by Fisher & Paykel Healthcare, Ltd.
- Z-0158-2026 — Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
- Z-3262-2024 — 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 infant, child, adolescent and adult patients in hospitals and sub-acute facilities.
- Z-1823-2024 — Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
- Z-0210-2015 — 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 and is used by labor and delivery rooms and pediatric intensive care units. Infant Warmers Model Number (REF) IW910XXX, IW920XXX, IW931XXX, IW932XXX, IW933XXX, IW934XXX, IW951XXX, IW952XXX, IW953XXX, IW954XXX, IW980XXX, IW990XXX Spare Parts Model Number (REF) 043041129, 043041130, 043041131, 043042359, 648040142
- Z-1539-2014 — 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, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface.
- Z-1437-2013 — 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 CPAP unit is for use on adult patients for the treatment of Obstructive Sleep Apnea (OSA). The device is for use in the home or sleep laboratory. The device is not intended to be used as a life supporting device.
- Z-0621-2013 — Fisher & Paykel Healthcare reusable breathing circuit. Non-heated breathing circuit, 1.8m or 6 feet in length. Oxygen therapy delivery system for adult patient.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Fisher & Paykel Healthcare, Ltd.
- K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
- K250651 — OptiPAP Junior Flexi Tube US (OPTIPAPFUS) +10 more
- K252173 — F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A) +3 more
- K243917 — F&P Optiflow Air/Oxygen Flow Source
- K251611 — Optiflow+ Nasal Cannula - Small (OPT942) +5 more
- K233643 — F&P Airvo 3 NIV (PT311US)
- K234053 — F&P Optiflow Flow Diverter
- K234058 — F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J)
- K233821 — F&P Optiflow Oxygen Kit (AA451J)
- K231956 — F&P Optiflow+ Duet Nasal Cannula
- K223684 — F&P 820 Humidification System
- K221436 — F&P 950 Accessory Breathing Circuit Kits
- K223696 — F&P Solo Mask Range
- K222197 — F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range
- K212031 — F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
- K212371 — F&P Evora Full Face Mask
- K211096 — Optiflow Oxygen Kit
- K203449 — F&P Visairo NIV Mask Range
- K201723 — F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
- 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
- K191818 — F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
- K190713 — F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)
- K173193 — F&P SleepStyle
- K161686 — F&P InfoSmart
- K161412 — F&P Brevida Nasal Pillows Mask
- K143646 — MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit
- K132017 — HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT
- K133666 — RT016 INSPIRATORY FILTER
- K131957 — MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT
- K131895 — AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER
- K121975 — AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
- K122432 — ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
- K103767 — DUAL HEATED INFANT VREATHING CIROUITS
- K110019 — RESPIRATORY HUMIDIFER
- K110316 — INFOSEND GSM
- K103786 — ZEST PETITE NASAL MASK
- K100011 — FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
- K100554 — RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441
- K094040 — F&P ICON SERIES CPAP
- K092846 — AIRVO SERIES HUMIDIFIERS
- K083832 — ZEST NASAL MASK
- K083122 — HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
- K080209 — FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK
- K081029 — SLEEPSTYLE 200 AUTO SERIES HC254
- K073706 — RESPIRATORY HUMIDIFIER, MODEL MR850
- K063036 — OPUS HC482 DIRECT NASAL MASK
- K061236 — FLEXIFIT HC432 FULL FACE MASK
- K060044 — ACUTE CARE FACE MASK, MODEL RT040
- K050927 — RT019 INSPIRATORY/EXPIRATORY FILTER
- K050904 — CPAP HUMIDIFIER, MODEL HC238JHU
- K034026 — RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
- K041900 — HC604 CPAP HUMIDIFIER
- K040941 — CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
- K040506 — FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
- K033710 — MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU
- K040366 — PRESSURE MANIFOLD, MODEL BC 110
- K033087 — ORACLE ORAL MASK, MODEL HC451A
- K020332 — RESPIRATORY HUMIDIFIER, MODEL MR850
- K023559 — FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
- K023670 — SINGLE USE ORAL MASK, MODEL HC455A
- K022609 — SURGICAL PATIENT WARMER, MODEL PW820 JHU
- K002839 — END EXPIRATORY FILTER, MODEL RT020
- K003894 — ORACLE ORAL MASK
- K003973 — RESPIRATORY HUMIDIFIER, MODEL HC150
- K002414 — PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE
- K983112 — RESPIRATORY HUMIDIFIER, MODEL # MR850
- K982636 — PATIENT WARMER- MODEL PW810
- K953205 — CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION)
- K881970 — MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
- K882438 — CONSTANT CURRENT PERIPHERAL NERVE STIM. #NS252
Data sourced from openFDA. This site is unofficial and independent of the FDA.