Cleared Traditional

DUMEX IODOFORM PACKING STRIP (K990332) - FDA 510(k) Clearance

K990332 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device

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Apr 1999

Decision

70d

Days

Risk

K990332 is an FDA 510(k) clearance for the DUMEX IODOFORM PACKING STRIP. 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 April 14, 1999 after a review of 70 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 Dumex Medical Surgical Products, Ltd. devices

Submission Details

510(k) Number	K990332 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	February 03, 1999
Decision Date	April 14, 1999
Days to Decision	70 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

45d faster than avg

Panel avg: 115d · This submission: 70d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	FRO Dressing, Wound, Drug
Device Class	-

Regulatory Peers - FRO Dressing, Wound, Drug

All 163

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K990332.

SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)

K042164 · Medline Industries, Inc. · Jun 2005

ACTICOAT MOISTURE CONTROL DRESSING

K050030 · Smith & Nephew, Inc. · Apr 2005

3M TEGADERM SILVER

K040890 · 3M Company · Nov 2004

TEGASORB(TM) ULCER DRESSING, #90-XXX

K891288 · 3M Company · Jun 1989

PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH

K885045 · Baxter Healthcare Corp · Mar 1989

PHARMASEAL STERILE WOUND CARE DRESSING

K884397 · Baxter Healthcare Corp · Dec 1988

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 K990332

Dumex Medical Surgical Products, Ltd.

Toronto, Orntario · CA

SHARMINI ATHERAY

Regulatory profile

13 submissions 10 cleared

77% 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.

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