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FDA 510(k)

F&P Optiflow Air/Oxygen Flow Source

K-Number: K243917 · 2025-07-14

ApplicantFisher & Paykel Healthcare, Ltd.
Decision Date2025-07-14
Product CodeBZR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

F&P Optiflow Air/Oxygen Flow Source is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2025-07-14 under 510(k) number K243917. The device is classified under product code BZR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the F&P Optiflow Air/Oxygen Flow Source?

F&P Optiflow Air/Oxygen Flow Source is a medical device that received FDA 510(k) clearance on 2025-07-14. The listed applicant is Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K243917.

When did F&P Optiflow Air/Oxygen Flow Source receive FDA 510(k) clearance?

F&P Optiflow Air/Oxygen Flow Source received FDA 510(k) clearance on 2025-07-14, under 510(k) number K243917.

Who is the listed applicant for F&P Optiflow Air/Oxygen Flow Source?

The FDA 510(k) record lists Fisher & Paykel Healthcare, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for F&P Optiflow Air/Oxygen Flow Source?

The FDA product code for F&P Optiflow Air/Oxygen Flow Source is BZR.

Related Clinical Trials

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NCT07515716Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal AnesthesiaNOT_YET_RECRUITINGNCT07791992Combination of High-flow Nasal Oxygen (Optiflow) and Vibrating Membrane Nebuliser (Aerogen) in the Pre-hospital Setting - Before/After StudyWITHDRAWNNCT01887015Optiflow® to Prevent Post-Extubation Hypoxemia afteR Abdominal Surgery (the OPERA Trial)COMPLETEDNCT02389166Optiflow in Sequential Non-Invasive VentilationCOMPLETEDNCT03554863High Flow Oxygen in Patients Undergoing Surgery Under General AnesthesiaCOMPLETEDNCT04055077Influence of HFNO on Respiratory Stability in Patients of Different ASA Risk During Moderate Multimodal Analgo-sedation for Pars Plana VitrectomyCOMPLETED

Other records listing Fisher & Paykel Healthcare, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)K250651OptiPAP 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 JunK252173F&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 FullK251611Optiflow+ 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)K243583F&P Nova Nasal MaskK234053F&P Optiflow Flow Diverter

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Related Devices (Code: BZR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241465Midas Flowmeter; eAVSParker Hannifin CorporationK231895Maxtec MaxBlend2+pMaxtec, LLCK230987FlowStar Analog Mixer FlowmeterBaldus Sedation GmbH & Co. KGK222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KGK221494Quality Mix Blender, OxymixerDehas Medical Systems GmbHK202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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