510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K925249Substantially Equivalent

Cmi Stoma Covers

Community Medical Center, Spokane WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925249 is the FDA 510(k) clearance record for CMI STOMA COVERS, a class II device, cleared for Community Medical Center on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list one 510(k) clearance for Community Medical Center. As of , FDA records show no recalls naming K925249.

Clearance record

Decision date
Received
(48 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Community Medical Center Grand Ave., Spokane WA
510(k) summary
Summary
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