Cleared Traditional

K983554 - ALLDRESS

K983554 is an FDA 510(k) clearance for ALLDRESS, manufactured by Molnlycke Health Care, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K983554 · Molnlycke Health Care, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
28d
Days
Class 1
Risk

K983554 is an FDA 510(k) clearance for the ALLDRESS, ABSORBENT FILM DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Molnlycke Health Care, Inc. (Eddystone, US). The FDA issued a Cleared decision on November 10, 1998 after a review of 28 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 Molnlycke Health Care, Inc. devices

FDA 510(k) Submission Details - K983554

510(k) Number K983554 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 13, 1998
Decision Date November 10, 1998
Days to Decision 28 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 115d · This submission: 28d
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 80
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K983554.
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
3M TEGASORB THIN HYDROCOLLOID DRESSING
K982892 · 3M Company · Oct 1998
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · 3M Company · Oct 1998
NONWOVEN PAD
K980720 · Convatec, A Division of E.R. Squibb & Sons · Apr 1998