Cleared Traditional

K860085 - LYOFOAM WOUND DRESSINGS

K860085 is an FDA 510(k) clearance for LYOFOAM WOUND DRESSINGS, manufactured by Acme United Corp.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K860085 · Acme United Corp. · General & Plastic Surgery device
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Jun 1986
Decision
169d
Days
Class 1
Risk

K860085 is an FDA 510(k) clearance for the LYOFOAM WOUND DRESSINGS. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by Acme United Corp. (Fairfield, US). The FDA issued a Cleared decision on June 27, 1986 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Acme United Corp. devices

FDA 510(k) Submission Details - K860085

510(k) Number K860085 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 09, 1986
Decision Date June 27, 1986
Days to Decision 169 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
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 52
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K860085.
DRESSING, BURN, 24 BY 36 INCHES
K870239 · Fraass Survival Systems, Inc. · Feb 1987
EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES
K864011 · Fraass Survival Systems, Inc. · Nov 1986
WOUND MANAGER(TM) - STERILE
K862935 · Convatec, A Division of E.R. Squibb & Sons · Aug 1986
OPSITE WOUND DRESSING
K852211 · Smith & Nephew, Inc. · Jul 1985
CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
K851382 · Chesebrough-Pond'S U.S.A. Co. · Jul 1985
BLISTERFILM TRANSPARENT DRESSING
K851383 · Chesebrough-Pond'S U.S.A. Co. · Jul 1985