Cleared Special

K012842 - V*CARE MANUAL RESUSCITATOR (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K012842 · Ventlab Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
26d
Days
Class 2
Risk

K012842 is an FDA 510(k) clearance for the V*CARE MANUAL RESUSCITATOR. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Ventlab Corp. (Mocksville, US). The FDA issued a Cleared decision on September 18, 2001 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ventlab Corp. devices

Submission Details

510(k) Number K012842 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2001
Decision Date September 18, 2001
Days to Decision 26 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 139d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Peers - BTM Ventilator, Emergency, Manual (resuscitator)

All 208
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K012842.
The BAG manual resuscitator and accessories
K251631 · Laerdal Medical AS · Nov 2025
butterflyBVM
K243861 · Compact Medical, Inc. · Apr 2025
EOlife®
K221841 · Archeon · Mar 2023
Sotair Device
K212905 · Safe Bvm Corporation · Aug 2022
Disposable Manual Resuscitator
K210288 · Xiamen Compower Medical Tech. Co., Ltd. · Aug 2021