Cleared Traditional

K093081 - POCKET BVM

K093081 is an FDA 510(k) clearance for POCKET BVM, manufactured by Microbvm Systems , Ltd.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K093081 · Microbvm Systems , Ltd. · Anesthesiology device
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Feb 2010
Decision
127d
Days
Class 2
Risk

K093081 is an FDA 510(k) clearance for the POCKET BVM. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Microbvm Systems , Ltd. (Efrat, IL). The FDA issued a Cleared decision on February 5, 2010 after a review of 127 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 Microbvm Systems , Ltd. devices

FDA 510(k) Submission Details - K093081

510(k) Number K093081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2009
Decision Date February 05, 2010
Days to Decision 127 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 140d · This submission: 127d
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 Peers - BTM Ventilator, Emergency, Manual (resuscitator)

All 102
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K093081.
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RESUSCITATION TIMER, MODEL L770-CPR
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