Cleared Traditional

K972530 - CONVATEC ODOR CONTROL WOUND DRESSING

K972530 is an FDA 510(k) clearance for CONVATEC ODOR CONTROL WOUND DRESSING, manufactured by Convatec, A Division of E.R. Squibb & Sons. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K972530 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
86d
Days
Class 1
Risk

K972530 is an FDA 510(k) clearance for the CONVATEC ODOR CONTROL WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Skillman, US). The FDA issued a Cleared decision on October 1, 1997 after a review of 86 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 Convatec, A Division of E.R. Squibb & Sons devices

FDA 510(k) Submission Details - K972530

510(k) Number K972530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1997
Decision Date October 01, 1997
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
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 147
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K972530.
BIODERM FOAM WOUND DRESSING
K973429 · Bioderm, Inc. · Dec 1997
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc. · Nov 1997
ALGINATE/ZINC WOUND DRESSING
K973283 · Innovative Technologies , Ltd. · Oct 1997
OPPORTUNITY DRESSING CHANGE TRAY
K971090 · Opportunity, Inc. · Sep 1997
OPPURTUNITY TRACHEOSTOMY CARE KIT
K971091 · Opportunity, Inc. · Sep 1997
CONVATEC NON-ADHESIVE DRESSING
K972062 · Convatec, A Division of E.R. Squibb & Sons · Aug 1997