Cleared Traditional

STERIL-DERM-PLUS TRANSPARENT DRESSING (K931766) - FDA 510(k) Clearance

K931766 · Biointerface Technologies, Inc. · General & Plastic Surgery device
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Jan 1995
Decision
656d
Days
-
Risk

K931766 is an FDA 510(k) clearance for the STERIL-DERM-PLUS TRANSPARENT DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Biointerface Technologies, Inc. (Madison, US). The FDA issued a Cleared decision on January 24, 1995 after a review of 656 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Biointerface Technologies, Inc. devices

Submission Details

510(k) Number K931766 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 08, 1993
Decision Date January 24, 1995
Days to Decision 656 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
541d slower than avg
Panel avg: 115d · This submission: 656d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K931766.
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