Cleared Traditional

K963656 - FOAM CALCIUM ALIGINATE TOPICAL WOUND DRESSING

K963656 is an FDA 510(k) clearance for FOAM CALCIUM ALIGINATE TOPICAL WOUND DR..., 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 61-day FDA review.

K963656 · Adri · General & Plastic Surgery device
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Nov 1996
Decision
61d
Days
Class 1
Risk

K963656 is an FDA 510(k) clearance for the FOAM CALCIUM ALIGINATE 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 November 12, 1996 after a review of 61 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.

View all Adri devices

FDA 510(k) Submission Details - K963656

510(k) Number K963656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1996
Decision Date November 12, 1996
Days to Decision 61 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 115d · This submission: 61d
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 K963656.
INNOVATIVE TECHNOLOGIES ALIGINATE/PECTIN WOUND DRESSINGS
K963598 · Innovative Technologies , Ltd. · Nov 1996
DERMAGRAN HYDROPHILIC OINTMENT
K963603 · Derma Sciences, Inc. · Nov 1996
OSMOCYTE ULTRA/PE PILLOW WOUND DRESSING
K962623 · Procyte Corp. · Nov 1996
BIODERM PVP FOAM WOUND DRESSING
K963602 · Bioderm, Inc. · Oct 1996
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · Smith & Nephew United, Inc. · Oct 1996
PROD NO. 01-1694 - 4X4 FOAM DRESSING
K954728 · Continental Medical Laboratories, Inc. · Sep 1996