Cleared Traditional

K935783 - MITRAFLEX CAVITY WOUND DRESSING

K935783 is an FDA 510(k) clearance for MITRAFLEX CAVITY WOUND DRESSING, manufactured by Polymedica Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K935783 · Polymedica Industries, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
60d
Days
Class 1
Risk

K935783 is an FDA 510(k) clearance for the MITRAFLEX CAVITY WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on February 4, 1994 after a review of 60 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.

FDA 510(k) Submission Details - K935783

510(k) Number K935783 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 06, 1993
Decision Date February 04, 1994
Days to Decision 60 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
55d faster than avg
Panel avg: 115d · This submission: 60d
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 208
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K935783.
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K923299 · Aplicare, Inc. · Jan 1994
ALLKARE BARRIER WIPE
K925004 · Convatec, A Division of E.R. Squibb & Sons · Jan 1994
K935783 · MITRAFLEX CAVITY WOUND DRESSING
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