510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895162Substantially Equivalent

Traumafuse Trach Shield

The Traumafuse Co., Allentown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895162 is the FDA 510(k) clearance record for TRAUMAFUSE TRACH SHIELD, a class II device, cleared for The Traumafuse Co. on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list 4 510(k) clearances for The Traumafuse Co., from to . As of , FDA records show no recalls naming K895162.

Clearance record

Decision date
Received
(140 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
The Traumafuse Co. 2340 Riverbend Rd., Allentown PA
Third party review
No

Clearances, product code BTO

Trailing 12 months
1 clearance under product code BTO in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTO, 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 20261
October 20260