Cleared Traditional

K982116 - AQUACEL HYDROFIBER WOUND DRESSING

K982116 is an FDA 510(k) clearance for AQUACEL HYDROFIBER WOUND DRESSING, manufactured by Convatec, A Bristol-Myers Squibb Co.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K982116 · Convatec, A Bristol-Myers Squibb Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
84d
Days
Class 1
Risk

K982116 is an FDA 510(k) clearance for the AQUACEL HYDROFIBER WOUND DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Convatec, A Bristol-Myers Squibb Co. (Skillman, US). The FDA issued a Cleared decision on September 8, 1998 after a review of 84 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 Bristol-Myers Squibb Co. devices

FDA 510(k) Submission Details - K982116

510(k) Number K982116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1998
Decision Date September 08, 1998
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 154
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K982116.
3M TEGASORB HYDROCOLLOID DRESSING
K982893 · 3M Company · Oct 1998
BIODERM FOAM WOUND DRESSING
K982778 · Bioderm, Inc. · Oct 1998
HOSPAL TIPSTOP
K982818 · Gambro Healthcare · Oct 1998
AL-GEN CALCIUM ALGINATE DRESSING
K982234 · Innovative Technologies , Ltd. · Sep 1998
THALAFIX NATURAL SEA SALT DRESSING
K980779 · Dumex Medical Surgical Products, Ltd. · Jun 1998
3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING
K980989 · Innovative Technologies , Ltd. · May 1998