Cleared Traditional

K974205 - KNITTED WOUND DRESSING-STANDARD

K974205 is the FDA 510(k) clearance for KNITTED WOUND DRESSING-STANDARD 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 88-day FDA review.

K974205 · 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
88d
Days
Class 1
Risk

K974205 is an FDA 510(k) clearance for the KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON. 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 6, 1998 after a review of 88 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 K974205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1997
Decision Date February 06, 1998
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 K974205.
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
NONWOVEN DRESSING
K974823 · 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
STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700)
K973228 · Smith & Nephew, Inc. · Nov 1997