Cleared Traditional

K964231 - NASP HYDROCOLLOID DRESSING (REGULAR OR THIN)

K964231 is an FDA 510(k) clearance for NASP HYDROCOLLOID DRESSING (REGULAR OR ..., manufactured by North American Sterilization & Packaging Co.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K964231 · North American Sterilization & Packaging Co. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
138d
Days
Class 1
Risk

K964231 is an FDA 510(k) clearance for the NASP HYDROCOLLOID DRESSING (REGULAR OR THIN). Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by North American Sterilization & Packaging Co. (Sparta, US). The FDA issued a Cleared decision on March 10, 1997 after a review of 138 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 North American Sterilization & Packaging Co. devices

FDA 510(k) Submission Details - K964231

510(k) Number K964231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1996
Decision Date March 10, 1997
Days to Decision 138 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
23d slower than avg
Panel avg: 115d · This submission: 138d
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 95
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K964231.
CONVATEC ODOR CONTROL WOUND DRESSING
K972530 · Convatec, A Division of E.R. Squibb & Sons · Oct 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · Convatec, A Division of E.R. Squibb & Sons · Aug 1997
DERMAGRAN WOUND MANAGEMENT SYSTEM
K970660 · Derma Sciences, Inc. · Aug 1997
TIELLE HYDROPOLYMER FOAM DRESSING
K964016 · Johnson & Johnson Medical, Inc. · Dec 1996
DERMAGRAN HYDROPHILIC OINTMENT
K963603 · Derma Sciences, Inc. · Nov 1996
ALLEVYN HYDRO POLY DRESSING ND ALL TRAC DRESSING
K963096 · Smith & Nephew United, Inc. · Oct 1996