Cleared Traditional

K941176 - ALGINATE FIBER

K941176 is an FDA 510(k) clearance for ALGINATE FIBER, manufactured by Adri/Technam. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K941176 · Adri/Technam · General & Plastic Surgery device
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Jul 1994
Decision
136d
Days
Class 1
Risk

K941176 is an FDA 510(k) clearance for the ALGINATE FIBER. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Adri/Technam (Park Forest, US). The FDA issued a Cleared decision on July 28, 1994 after a review of 136 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/Technam devices

FDA 510(k) Submission Details - K941176

510(k) Number K941176 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 14, 1994
Decision Date July 28, 1994
Days to Decision 136 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
21d slower than avg
Panel avg: 115d · This submission: 136d
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 145
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K941176.
CAVI-CARE CONFORMING FOAM DRESSING
K943619 · Smith & Nephew United, Inc. · Aug 1994
SAF-GEL HYDRATING DERMAL WOUND DRESSING
K942270 · Calgon Vestal Div. · Aug 1994
HYDROCOLLOID WOUND DRESSING
K943258 · Convatec, A Division of E.R. Squibb & Sons · Aug 1994
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