Cleared Traditional

K954728 - PROD NO. 01-1694 - 4X4 FOAM DRESSING

K954728 is an FDA 510(k) clearance for PROD NO. 01-1694 - 4X4 FOAM DRESSING, manufactured by Continental Medical Laboratories, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 346-day FDA review.

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

FDA 510(k) Submission Details - K954728

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
231d slower than avg
Panel avg: 115d · This submission: 346d
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 139
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K954728.
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K962421 · Innovative Technologies , Ltd. · Jul 1996
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K961323 · Acme United Corp. · Jun 1996