Cleared Traditional

K990955 - MODIFICATION OF:BIODERM FOAM WOUND DRESSING

K990955 is an FDA 510(k) clearance for MODIFICATION OF:BIODERM FOAM WOUND DRESSING, manufactured by Bioderm, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K990955 · Bioderm, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
57d
Days
Class 1
Risk

K990955 is an FDA 510(k) clearance for the MODIFICATION OF:BIODERM FOAM WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Bioderm, Inc. (Wheaton, US). The FDA issued a Cleared decision on May 18, 1999 after a review of 57 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 Bioderm, Inc. devices

FDA 510(k) Submission Details - K990955

510(k) Number K990955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1999
Decision Date May 18, 1999
Days to Decision 57 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
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 75
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K990955.
3M LIQUID BANDAGE
K053409 · 3M Company · Jun 2006
RESTORE WOUND CLEANSER
K040779 · Hollister, Inc. · May 2004
3M LIQUID BANDAGE, MODEL 120-LB
K031263 · 3M Company · Oct 2003
ASKINA HYDROCOLLOID/THIN
K973227 · B.Braun Medical, Inc. · Jan 1999
COMFEEL SEASORB DRESSING
K983519 · Coloplast Corp. · Dec 1998
ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998