Cleared Traditional

K974823 - NONWOVEN DRESSING

K974823 is an FDA 510(k) clearance for NONWOVEN 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 58-day FDA review.

K974823 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K974823

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.

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 K974823.
BIODERM CALCIUM ALGINATE DRESSING
K980451 · Bioderm, Inc. · Apr 1998
OSMO/PCA PILLOW WOUND DRESSING
K971612 · Procyte Corp. · Mar 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
OSMOCYTE ISLAND WOUND DRESSING
K972150 · Procyte Corp. · Dec 1997
OSMOCYTE RA WOUND DRESSING
K972329 · Procyte Corp. · Dec 1997