Cleared Traditional

K920399 - COMPOUND BENZOIN TINCTURE USP FREPP

K920399 is an FDA 510(k) clearance for COMPOUND BENZOIN TINCTURE USP FREPP, manufactured by Medi-Flex Hospital Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 726-day FDA review.

K920399 · Medi-Flex Hospital Products, Inc. · General & Plastic Surgery device
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Jan 1994
Decision
726d
Days
Class 1
Risk

K920399 is an FDA 510(k) clearance for the COMPOUND BENZOIN TINCTURE USP FREPP. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Medi-Flex Hospital Products, Inc. (Overland Park, US). The FDA issued a Cleared decision on January 25, 1994 after a review of 726 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Medi-Flex Hospital Products, Inc. devices

FDA 510(k) Submission Details - K920399

510(k) Number K920399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1992
Decision Date January 25, 1994
Days to Decision 726 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
611d slower than avg
Panel avg: 115d · This submission: 726d
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 108
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K920399.
FERRIS POLYMEM HYDROPHILIC WOUND DRESSING
K932913 · Ferris Mfg. Corp. · Jun 1994
3M TEGASORB HYDROCOLLOID DRESSING
K940624 · 3M Company · May 1994
MITRAFLEX CAVITY WOUND DRESSING
K935783 · Polymedica Industries, Inc. · Feb 1994
ALLKARE BARRIER WIPE
K925004 · Convatec, A Division of E.R. Squibb & Sons · Jan 1994
BRENNEN MEDICAL STERILE SALINE SOLUTION
K935060 · Brennen Medical, Inc. · Jan 1994
EPIDRESS & DERMASORB HYDROCOLLOID ALGINATE DRESSIN
K926230 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993