Cleared Traditional

K974823 - NONWOVEN DRESSING

K974823 is the FDA 510(k) clearance for NONWOVEN DRESSING by Convatec, A Division of E.R. Squibb & Sons. It is a Class 1 General & Plastic Surgery device (product code KMF) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K974823 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Feb 1998
Decision
58d
Days
Class 1
Risk

K974823 is an FDA 510(k) clearance for the NONWOVEN 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 February 20, 1998 after a review of 58 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

Submission Details

510(k) Number K974823 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 24, 1997
Decision Date February 20, 1998
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 68
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K974823.
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · 3M Company · Oct 1998
NONWOVEN PAD
K980720 · Convatec, A Division of E.R. Squibb & Sons · Apr 1998
NON-WOVEN COMPRESS
K980382 · Convatec, A Division of E.R. Squibb & Sons · Mar 1998
KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
K974205 · Convatec, A Division of E.R. Squibb & Sons · Feb 1998
KENDALL CURITY NON-ADHERING DRESSING
K973619 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997
KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
K973509 · Kendall Healthcare Products Co. Div.Of Tyco Health · Dec 1997