510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912203Substantially Equivalent

Ems Single Use Manual Resuscitators

Engineered Medical Systems, LLC, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912203 is the FDA 510(k) clearance record for EMS SINGLE USE MANUAL RESUSCITATORS, a class II device, cleared for Engineered Medical Systems on under FDA product code BTM (Ventilator, Emergency, Manual (Resuscitator)). FDA records list 25 510(k) clearances for Engineered Medical Systems, from to . As of , FDA records show no recalls naming K912203.

Clearance record

Decision date
Received
(177 days to decision)
Product code
BTM Ventilator, Emergency, Manual (Resuscitator)
Regulation
21 CFR 868.5915
Device class
Class II
Review panel
Anesthesiology
Applicant
Engineered Medical Systems 8529 Zionsville Rd., Indianapolis IN
510(k) summary
Statement
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