Cleared Traditional

K940404 - ALGINATE FIBER TOPICAL WOUND DRESSING

K940404 is an FDA 510(k) clearance for ALGINATE FIBER TOPICAL WOUND DRESSING, manufactured by Adri. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K940404 · Adri · General & Plastic Surgery device
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May 1994
Decision
97d
Days
Class 1
Risk

K940404 is an FDA 510(k) clearance for the ALGINATE FIBER TOPICAL WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Adri (Park Forest, US). The FDA issued a Cleared decision on May 4, 1994 after a review of 97 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Adri devices

FDA 510(k) Submission Details - K940404

510(k) Number K940404 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 27, 1994
Decision Date May 04, 1994
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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 140
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K940404.
HYPERTONIC SALINE WET DRESSING - STERILE
K941999 · Trinity Laboratories, Inc. · Jun 1994
CURASALT HYPERTONIC SALINE DRESSING
K942459 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jun 1994
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