Cleared Traditional

K954918 - COMBIDERM ACD

K954918 is an FDA 510(k) clearance for COMBIDERM ACD, manufactured by Convatec, A Bristol-Myers Squibb Co.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K954918 · Convatec, A Bristol-Myers Squibb Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
61d
Days
Class 1
Risk

K954918 is an FDA 510(k) clearance for the COMBIDERM ACD. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Convatec, A Bristol-Myers Squibb Co. (Princeton, US). The FDA issued a Cleared decision on December 26, 1995 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery 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 Convatec, A Bristol-Myers Squibb Co. devices

FDA 510(k) Submission Details - K954918

510(k) Number K954918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1995
Decision Date December 26, 1995
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 74
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