Cleared Traditional

F&P Optiflow Air/Oxygen Flow Source

K243917 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology
Jul 2025
Decision
206d
Days
Class 2
Risk

About This 510(k) Submission

K243917 is an FDA 510(k) clearance for the F&P Optiflow Air/Oxygen Flow Source, a Mixer, Breathing Gases, Anesthesia Inhalation (Class II — Special Controls, product code BZR), submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on July 14, 2025, 206 days after receiving the submission on December 20, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5330.

Submission Details

510(k) Number K243917 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2024
Decision Date July 14, 2025
Days to Decision 206 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZR — Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5330

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