Cleared Traditional

K901155 - DUODERM* CONTROL GEL FORMULA BORDER DRE...

K901155 is the FDA 510(k) clearance for DUODERM* CONTROL GEL FORMULA BORDER DRE... 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 34-day FDA review.

K901155 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
34d
Days
Class 1
Risk

K901155 is an FDA 510(k) clearance for the DUODERM* CONTROL GEL FORMULA BORDER DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on April 16, 1990 after a review of 34 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 K901155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1990
Decision Date April 16, 1990
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 K901155.
INTRASITE GEL (LABELING REVISION)
K904411 · Smith & Nephew United, Inc. · Nov 1990
ALLEVYN DRESSING (LABELING REVISED)
K901877 · Smith & Nephew United, Inc. · Jun 1990
INTRASITE GEL (LABELING REVISION)
K901878 · Smith & Nephew United, Inc. · Jun 1990
MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL
K895819 · Medi-Tech, Inc. · Nov 1989
VIGILON PRIMARY WOUND DRESSING, STERILE
K820134 · C.R. Bard, Inc. · Feb 1982
HYDRON WOUND DRESSING KIT
K811446 · National Patent Development Corp. · Jun 1981