Cleared Traditional

K830089 - BURN DRESSING

K830089 is an FDA 510(k) clearance for BURN DRESSING, manufactured by Action Medical Systems, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K830089 · Action Medical Systems, Inc. · General & Plastic Surgery device
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Mar 1983
Decision
56d
Days
Class 1
Risk

K830089 is an FDA 510(k) clearance for the BURN DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Action Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1983 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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 Action Medical Systems, Inc. devices

FDA 510(k) Submission Details - K830089

510(k) Number K830089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date March 08, 1983
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K830089.
LASTOBAND ADHESIVE BANDAGES
K831454 · Smith & Nephew, Inc. · Oct 1983
ENSURE DRESSING
K830593 · Warner-Lambert Co. · Apr 1983
CHESEBROUGH-POND'S MULTILAYER ELASTIC
K823852 · Chesebrough-Pond'S U.S.A. Co. · Mar 1983
ADHESIVE WOUND COVER FILM
K822080 · Hollister, Inc. · Oct 1982
PEDIBAND CAT.#195-197
K802021 · Pollak (Intl.), Ltd. · Sep 1980
FIXOMULL STERILE
K800953 · Beiersdorf, Inc. · May 1980