Cleared Traditional

butterflyBVM

K243861 · Compact Medical, Inc. · Anesthesiology
Apr 2025
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K243861 is an FDA 510(k) clearance for the butterflyBVM, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Compact Medical, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 25, 2025, 130 days after receiving the submission on December 16, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K243861 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2024
Decision Date April 25, 2025
Days to Decision 130 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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