Cleared Traditional

K243861 - butterflyBVM

K243861 is an FDA 510(k) clearance for butterflyBVM, manufactured by Compact Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 130-day FDA review.

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

K243861 is an FDA 510(k) clearance for the butterflyBVM. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Compact Medical, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 25, 2025 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Compact Medical, Inc. devices

FDA 510(k) Submission Details - K243861

510(k) Number K243861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 140d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

RQM+
Allison Komiyama

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTM Ventilator, Emergency, Manual (resuscitator)

All 82
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K243861.
The BAG manual resuscitator and accessories
K251631 · Laerdal Medical AS · Nov 2025
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K221841 · Archeon · Mar 2023
Sotair Device
K212905 · Safe Bvm Corporation · Aug 2022
Disposable Manual Resuscitator
K210288 · Xiamen Compower Medical Tech. Co., Ltd. · Aug 2021
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
K181583 · Flexicare Medical Limited. · Dec 2018
Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer
K170663 · Foremount Enterprise Co., Ltd. · May 2018