Cleared Traditional

F&P Nova Nasal Mask

K243583 · Fisher & Paykel Healthcare Limited · Anesthesiology
Jun 2025
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K243583 is an FDA 510(k) clearance for the F&P Nova Nasal Mask, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by Fisher & Paykel Healthcare Limited (Auckland, NZ). The FDA issued a Cleared decision on June 18, 2025, 210 days after receiving the submission on November 20, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K243583 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2024
Decision Date June 18, 2025
Days to Decision 210 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZD — Ventilator, Non-continuous (respirator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5905

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