510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K052743Substantially Equivalent

Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921

Dynarex Corp., Orangeburg NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052743 is the FDA 510(k) clearance record for DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MODEL 4921, a class II device, cleared for Dynarex Corp. on under FDA product code CBP (Valve, Non-Rebreathing). FDA records list 27 510(k) clearances for Dynarex Corp., from to . As of , FDA records show one recall naming K052743.

Clearance record

Decision date
Received
(83 days to decision)
Product code
CBP Valve, Non-Rebreathing
Regulation
21 CFR 868.5870
Device class
Class II
Review panel
Anesthesiology
Applicant
Dynarex Corp. 10 Glenshaw St., Orangeburg NY
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