510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853345Substantially Equivalent

31St. Centruy Medical Corp Time Buyer 428905 US Pe

31st. Centruy Medical Corp., Pittsburgh PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853345 is the FDA 510(k) clearance record for 31ST. CENTRUY MEDICAL CORP TIME BUYER 428905 US PE, a class II device, cleared for 31st. Centruy Medical Corp. on under FDA product code BWC (Needle, Emergency Airway). FDA records list one 510(k) clearance for 31st. Centruy Medical Corp. As of , FDA records show no recalls naming K853345.

Clearance record

Decision date
Received
(50 days to decision)
Product code
BWC Needle, Emergency Airway
Regulation
21 CFR 868.5090
Device class
Class II
Review panel
Anesthesiology
Applicant
31st. Centruy Medical Corp. 435 Old Hickory Dr., Pittsburgh PA
Third party review
No

Clearances, product code BWC

Trailing 12 months

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

FDA records show no clearances under product code BWC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BWC, 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