Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Fisher & Paykel Healthcare, Ltd.. It received FDA 510(k) clearance on 2025-07-14 under approval 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. It is manufactured by Fisher & Paykel Healthcare, Ltd.. The 510(k) number is K243917.

When was F&P Optiflow Air/Oxygen Flow Source approved by the FDA?

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

What company makes F&P Optiflow Air/Oxygen Flow Source?

F&P Optiflow Air/Oxygen Flow Source is manufactured by Fisher & Paykel Healthcare, Ltd..

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

NCT02389166 Optiflow in Sequential Non-Invasive Ventilation COMPLETED NCT07494773 Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection NOT_YET_RECRUITING NCT03554863 High Flow Oxygen in Patients Undergoing Surgery Under General Anesthesia COMPLETED NCT07515716 Effects of High Flow Humidified Oxygen on Umbilical Artery Acid-base Balance in Cesarean Section Under Spinal Anesthesia NOT_YET_RECRUITING

Other Devices by Fisher & Paykel Healthcare, Ltd.

K161686F&P InfoSmart K161412F&P Brevida™ Nasal Pillows Mask K173193F&P SleepStyle K190713F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) K200089F&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 K191818F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)

View all 25 devices →

Related Devices (Code: BZR)

K161718MaxBlend 2, MaxBlend LiteMaxtec, LLC K173205Equinox AdvantageO-Two Medical Technologies, Inc. K202480Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50Parker Hannifin K231895Maxtec MaxBlend2+pMaxtec, LLC K230987FlowStar Analog Mixer FlowmeterBaldus Sedation GmbH & Co. KG K222794FlowStar Touch Digital Mixer FlowmeterBaldus Sedation GmbH & Co. KG

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.

↑