Cleared Traditional

K864084 - LYOFOAM C ODOR-ABSORBING DRESSING

K864084 · Acme United Corp. · General & Plastic Surgery device

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Nov 1986

Decision

32d

Days

Risk

K864084 is an FDA 510(k) clearance for the LYOFOAM C ODOR-ABSORBING DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Acme United Corp. (Fairfield, US). The FDA issued a Cleared decision on November 21, 1986 after a review of 32 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Acme United Corp. devices

Submission Details

510(k) Number	K864084 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	October 20, 1986
Decision Date	November 21, 1986
Days to Decision	32 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

83d faster than avg

Panel avg: 115d · This submission: 32d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 224

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K864084.

CUTINOVA(R) PLUS FOAM GELFILM

K864913 · Beiersdorf, Inc. · Jul 1987

AMERICAN PHARMASEAL WOUND DRESSING

K871770 · American Pharmaseal Div. Ahsc · Jun 1987

VISCOPASTE ZINC PASTE BANDAGE

K863930 · Smith & Nephew, Inc. · Dec 1986

CHESEBROUGH POND'S HYDROCOLLOID DRESSING

K862803 · Chesebrough-Pond'S U.S.A. Co. · Nov 1986

HYDROCOLLOID DRESSINGS - STERILE

K863390 · Convatec, A Division of E.R. Squibb & Sons · Sep 1986

HOLLISTER WOUND CARE BARRIER

K862572 · Hollister, Inc. · Aug 1986

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K864084

Acme United Corp.

Fairfield, CT · US

SUSAN L CAREY

Regulatory profile

27 submissions 23 cleared

85% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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