510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K112126Substantially Equivalent

Genuine First Aid CPR Mask

Genuine First Aid, LLC, East Stroudsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112126 is the FDA 510(k) clearance record for GENUINE FIRST AID CPR MASK, a class II device, cleared for Genuine First Aid, LLC on under FDA product code CBP (Valve, Non-Rebreathing). FDA records list 2 510(k) clearances for Genuine First Aid, LLC, from to . As of , FDA records show no recalls naming K112126.

Clearance record

Decision date
Received
(129 days to decision)
Product code
CBP Valve, Non-Rebreathing
Regulation
21 CFR 868.5870
Device class
Class II
Review panel
Anesthesiology
Applicant
Genuine First Aid, LLC 150 Cherry Ln. Rd., East Stroudsburg PA
510(k) summary
Summary PDF
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