Cleared Traditional

myAir

K250624 · ResMed Corp · Anesthesiology
May 2025
Decision
86d
Days
Class 2
Risk

About This 510(k) Submission

K250624 is an FDA 510(k) clearance for the myAir, a Ventilator, Non-continuous (respirator) (Class II — Special Controls, product code BZD), submitted by ResMed Corp (San Diego, US). The FDA issued a Cleared decision on May 28, 2025, 86 days after receiving the submission on March 3, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number K250624 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2025
Decision Date May 28, 2025
Days to Decision 86 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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