Cleared Traditional

The BAG manual resuscitator and accessories

K251631 · Laerdal Medical AS · Anesthesiology
Nov 2025
Decision
180d
Days
Class 2
Risk

About This 510(k) Submission

K251631 is an FDA 510(k) clearance for the The BAG manual resuscitator and accessories, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Laerdal Medical AS (Stavanger, NO). The FDA issued a Cleared decision on November 24, 2025, 180 days after receiving the submission on May 28, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K251631 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2025
Decision Date November 24, 2025
Days to Decision 180 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

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