Cleared Traditional

K925249 - CMI STOMA COVERS

K925249 is an FDA 510(k) clearance for CMI STOMA COVERS, manufactured by Community Medical Center. The device is a Class 2 Anesthesiology device with product code BTO cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K925249 · Community Medical Center · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
48d
Days
Class 2
Risk

K925249 is an FDA 510(k) clearance for the CMI STOMA COVERS. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Community Medical Center (Spokane, US). The FDA issued a Cleared decision on December 3, 1992 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Community Medical Center devices

FDA 510(k) Submission Details - K925249

510(k) Number K925249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1992
Decision Date December 03, 1992
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 140d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTO Device Classification - Class 2, Special Controls

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTO Tube, Tracheostomy (w/wo Connector)

All 82
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K925249.
TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
K924194 · American Healthcare Corp. · Jan 1993
TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
K924195 · American Healthcare Corp. · Jan 1993
TRACHEOSTOMY CARE SET WITH GLOVES
K923834 · American Healthcare Corp. · Dec 1992
LOW PROFILE TRACHEOSTOMY TUBE
K922749 · Concord/Portex · Sep 1992
TRACHEOSTOMY CARE KIT, STERILE, DISPOSABLE
K920281 · Trinity Laboratories, Inc. · Aug 1992
TRACHEOSTOMY CARE KIT
K921281 · Trinity Laboratories, Inc. · Aug 1992