Cleared Traditional

K870352 - RUBYCELL(TM) SYNTHETIC ISLAND DRESSING

K870352 · Bioderm, Inc. · General & Plastic Surgery device

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Feb 1987

Decision

28d

Days

Risk

K870352 is an FDA 510(k) clearance for the RUBYCELL(TM) SYNTHETIC ISLAND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Bioderm, Inc. (Wheaton, US). The FDA issued a Cleared decision on February 26, 1987 after a review of 28 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 Bioderm, Inc. devices

FDA 510(k) Submission Details - K870352

510(k) Number	K870352 FDA.gov
FDA Decision	Cleared Substantially Equivalent - NSE Converted (SN)
Date Received	January 29, 1987
Decision Date	February 26, 1987
Days to Decision	28 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

87d faster than avg

Panel avg: 115d · This submission: 28d

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 227

Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K870352.

INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING

K872624 · Smith & Nephew, Inc. · Jul 1987

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

LYOFOAM C ODOR-ABSORBING DRESSING

K864084 · Acme United Corp. · Nov 1986

CHESEBROUGH POND'S HYDROCOLLOID DRESSING

K862803 · Chesebrough-Pond'S U.S.A. Co. · Nov 1986

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 K870352

Bioderm, Inc.

Wheaton, IL · US

OLIVIER A DELANNOY

Regulatory profile

14 submissions 10 cleared

71% clearance rate · Active in General & Plastic Surgery

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 . Updated monthly.

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