Cleared Traditional

K863389 - UNITED WOUND COVERING

K863389 · United Medical · General & Plastic Surgery device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Nov 1986

Decision

75d

Days

Risk

K863389 is an FDA 510(k) clearance for the UNITED WOUND COVERING, PACKAGE OF 5. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by United Medical (Largo, US). The FDA issued a Cleared decision on November 17, 1986 after a review of 75 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 United Medical devices

Submission Details

510(k) Number	K863389 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	September 03, 1986
Decision Date	November 17, 1986
Days to Decision	75 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

40d faster than avg

Panel avg: 115d · This submission: 75d

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 K863389.

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 K863389

United Medical

Largo, FL · US

MORTON M WYGODSKI

Regulatory profile

4 submissions 2 cleared

50% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active