Cleared Traditional

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

K242769 · Draegerwerk AG & CO Kgaa · Anesthesiology
Apr 2025
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K242769 is an FDA 510(k) clearance for the VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031), a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Draegerwerk AG & CO Kgaa (Luebeck, DE). The FDA issued a Cleared decision on April 4, 2025, 203 days after receiving the submission on September 13, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K242769 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2024
Decision Date April 04, 2025
Days to Decision 203 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTL — Ventilator, Emergency, Powered (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5925

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