Cleared Traditional

K954728 - PROD NO. 01-1694 - 4X4 FOAM DRESSING (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K954728 · Continental Medical Laboratories, Inc. · General & Plastic Surgery device
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Sep 1996
Decision
346d
Days
Class 1
Risk

K954728 is an FDA 510(k) clearance for the PROD NO. 01-1694 - 4X4 FOAM DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Continental Medical Laboratories, Inc. (Waterford, US). The FDA issued a Cleared decision on September 23, 1996 after a review of 346 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Continental Medical Laboratories, Inc. devices

Submission Details

510(k) Number K954728 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 13, 1995
Decision Date September 23, 1996
Days to Decision 346 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 114d · This submission: 346d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.