510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983919Substantially Equivalent

Ems Mouth to Mask Resuscitators

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

K983919 is the FDA 510(k) clearance record for EMS MOUTH TO MASK RESUSCITATORS, a class II device, cleared for Engineered Medical Systems on under FDA product code CBP (Valve, Non-Rebreathing). FDA records list 25 510(k) clearances for Engineered Medical Systems, from to . As of , FDA records show no recalls naming K983919.

Clearance record

Decision date
Received
(154 days to decision)
Product code
CBP Valve, Non-Rebreathing
Regulation
21 CFR 868.5870
Device class
Class II
Review panel
Anesthesiology
Applicant
Engineered Medical Systems 8529 Zionsville Rd., Indianapolis IN
510(k) summary
Summary
Third party review
No

Clearances, product code CBP

Trailing 12 months

FDA records hold no clearances under product code CBP in the trailing twelve months.

FDA records show no clearances under product code CBP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CBP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260