510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K093081Substantially Equivalent

Pocket Bvm

Microbvm Systems, Ltd., Efrat, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093081 is the FDA 510(k) clearance record for POCKET BVM, a class II device, cleared for Microbvm Systems , Ltd. on under FDA product code BTM (Ventilator, Emergency, Manual (Resuscitator)). FDA records list one 510(k) clearance for Microbvm Systems , Ltd. As of , FDA records show no recalls naming K093081.

Clearance record

Decision date
Received
(127 days to decision)
Product code
BTM Ventilator, Emergency, Manual (Resuscitator)
Regulation
21 CFR 868.5915
Device class
Class II
Review panel
Anesthesiology
Applicant
Microbvm Systems , Ltd. Pob 6718, Efrat, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTM

Trailing 12 months
1 clearance under product code BTM in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTM, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260