Cleared Traditional

K964701 - MITRAFLEX PIGMENTED WOUND DRESSING

K964701 · Polymedica Industries, Inc. · General & Plastic Surgery device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Feb 1997

Decision

74d

Days

Risk

K964701 is an FDA 510(k) clearance for the MITRAFLEX PIGMENTED WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Polymedica Industries, Inc. (Golden,, US). The FDA issued a Cleared decision on February 7, 1997 after a review of 74 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.

FDA 510(k) Submission Details - K964701

510(k) Number	K964701 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 25, 1996
Decision Date	February 07, 1997
Days to Decision	74 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

41d faster than avg

Panel avg: 115d · This submission: 74d

Pathway characteristics

Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 648

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K964701.

IT HYDROCOLLOID WITH ZINC

K973855 · Innovative Technologies , Ltd. · Dec 1997

ARGLAES FILM DRESSING

K970566 · Maersk Medical, Ltd. · Jul 1997

HYDROCOLLOID WOUND DRESSINGS

K971126 · Innovative Technologies , Ltd. · Jun 1997

SURESKIN STANDARD, BORDER, AND THIN

K963039 · Euromed A/S · Sep 1996

SIGNALDRESS

K962590 · Convatec, A Division of E.R. Squibb & Sons · Sep 1996

TECNOL SALINE WET DRESSING

K954243 · Tecnol Medical Products, Inc. · Nov 1995

FDA 510(k) Resources - General & Plastic Surgery

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

Manufacturer of K964701

Polymedica Industries, Inc.

Golden,, CO · US

JULIE CHAFFEE

Regulatory profile

16 submissions 13 cleared

81% clearance rate · Active in General & Plastic Surgery

View all devices by Polymedica Industries, Inc. →

About This 510(k) Record

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 . FDA decision: February 7, 1997. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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