Cleared Traditional

K980863 - DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)

K980863 is an FDA 510(k) clearance for DUMEX PAK-ITS NON-WOVEN DRESSING IMPREG..., manufactured by Dumex Medical Surgical Products, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K980863 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 1998
Decision
67d
Days
Class 1
Risk

K980863 is an FDA 510(k) clearance for the DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC). Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Dumex Medical Surgical Products, Ltd. (Toronto, Orntario, CA). The FDA issued a Cleared decision on May 11, 1998 after a review of 67 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 Dumex Medical Surgical Products, Ltd. devices

FDA 510(k) Submission Details - K980863

510(k) Number K980863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1998
Decision Date May 11, 1998
Days to Decision 67 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 115d · This submission: 67d
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 121
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K980863.
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
SPYROSORB FOAM ISLAND WOUND DRESSING
K980673 · Innovative Technologies (Us), Inc. · May 1998
NONWOVEN PAD
K980720 · Convatec, A Division of E.R. Squibb & Sons · Apr 1998
BIODERM CALCIUM ALGINATE DRESSING
K980451 · Bioderm, Inc. · Apr 1998
OSMO/PCA PILLOW WOUND DRESSING
K971612 · Procyte Corp. · Mar 1998