510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K953461Substantially Equivalent

CPR Mask & Related Family Kits

Safetec of America, Inc., Buffalo NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953461 is the FDA 510(k) clearance record for CPR MASK & RELATED FAMILY KITS, a class II device, cleared for Safetec of America, Inc. on under FDA product code CBP (Valve, Non-Rebreathing). FDA records list 4 510(k) clearances for Safetec of America, Inc., from to . As of , FDA records show no recalls naming K953461.

Clearance record

Decision date
Received
(164 days to decision)
Product code
CBP Valve, Non-Rebreathing
Regulation
21 CFR 868.5870
Device class
Class II
Review panel
Anesthesiology
Applicant
Safetec of America, Inc. 1055 E. Delavan Ave., Buffalo NY
510(k) summary
Statement
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