Cleared Traditional

K983519 - COMFEEL SEASORB DRESSING

K983519 is an FDA 510(k) clearance for COMFEEL SEASORB DRESSING, manufactured by Coloplast Corp.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K983519 · Coloplast Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
83d
Days
Class 1
Risk

K983519 is an FDA 510(k) clearance for the COMFEEL SEASORB DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Coloplast Corp. (Marietta, US). The FDA issued a Cleared decision on December 30, 1998 after a review of 83 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 Coloplast Corp. devices

FDA 510(k) Submission Details - K983519

510(k) Number K983519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1998
Decision Date December 30, 1998
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
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 145
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K983519.
FERRIS POLYMEM POLYWIC STERILE CAVITY WOUND FILLER
K990906 · Ferris Mfg. Corp. · Apr 1999
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
K984539 · Ferris Mfg. Corp. · Mar 1999
ASKINA HYDROCOLLOID/THIN
K973227 · B.Braun Medical, Inc. · Jan 1999
NUVO BARRIER FILM
K980117 · Biomedical Development Co. · Dec 1998
MODIFICATION TO SKVEKPATCH
K984177 · Marine Polymer Technologies, Inc. · Dec 1998
ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998