Cleared Traditional

IT HYDROCOLLOID WITH ZINC (K973855) - FDA 510(k) Clearance

K973855 · Innovative Technologies , Ltd. · General & Plastic Surgery device

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Dec 1997

Decision

53d

Days

Risk

K973855 is an FDA 510(k) clearance for the IT HYDROCOLLOID WITH ZINC. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Innovative Technologies , Ltd. (Winsford, Cheshire, GB). The FDA issued a Cleared decision on December 1, 1997 after a review of 53 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 Innovative Technologies , Ltd. devices

Submission Details

510(k) Number	K973855 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	October 09, 1997
Decision Date	December 01, 1997
Days to Decision	53 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

62d faster than avg

Panel avg: 115d · This submission: 53d

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 K973855.

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 K973855

Innovative Technologies , Ltd.

Winsford, Cheshire · GB

PRISCILLA WHITEHEAD COX

Regulatory profile

14 submissions 11 cleared

79% 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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