Cleared Traditional

K950132 - DUMEX WET DRESSINGS

K950132 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Mar 1995

Decision

47d

Days

Risk

K950132 is an FDA 510(k) clearance for the DUMEX WET DRESSINGS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Dumex Medical Surgical Products, Ltd. (Toronto, Orntario, CA). The FDA issued a Cleared decision on March 1, 1995 after a review of 47 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 - K950132

510(k) Number	K950132 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	January 13, 1995
Decision Date	March 01, 1995
Days to Decision	47 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

68d faster than avg

Panel avg: 115d · This submission: 47d

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 664

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K950132.

EX-111 WOUND DRESSING

K952907 · Variseal Manufacturing Corp. · Aug 1995

HOLLISTER HYDROCOLLOID WOUND DRESSINGS

K950933 · Hollister, Inc. · Jul 1995

ADHEROL SEPP APPLICATOR

K952007 · Medi-Flex Hospital Products, Inc. · Jun 1995

KIT PAK WET SALINE DRESSING

K942959 · Kit Pak, Inc. · Feb 1995

PREPPIES SKIN BARRIER WIPE

K945675 · Kendall Healthcare Products Co. Div.Of Tyco Health · Feb 1995

STERIL-DERM-PLUS TRANSPARENT DRESSING

K931766 · Biointerface Technologies, Inc. · Jan 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 K950132

Dumex Medical Surgical Products, Ltd.

Toronto, Orntario · CA

ANGELO GUERRIERO

Regulatory profile

13 submissions 10 cleared

77% clearance rate · Active in General & Plastic Surgery

View all devices by Dumex Medical Surgical Products, Ltd. →

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: March 1, 1995. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: October 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 176,325

Regulatory data since 1976

FDA monthly sync October 7, 2026