Cleared Traditional

K946292 - BIODERM MEDICAL COMPOSITE WOUND DRESSING

K946292 · Bioderm, Inc. · General & Plastic Surgery device

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Feb 1995

Decision

41d

Days

Risk

K946292 is an FDA 510(k) clearance for the BIODERM MEDICAL COMPOSITE WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Bioderm, Inc. (Wheaton, US). The FDA issued a Cleared decision on February 6, 1995 after a review of 41 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 - K946292

510(k) Number	K946292 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 27, 1994
Decision Date	February 06, 1995
Days to Decision	41 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

74d faster than avg

Panel avg: 115d · This submission: 41d

Pathway characteristics

Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code	MGP Dressing, Wound And Burn, Occlusive
Device Class	-

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 13

Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K946292.

ULTEC THIN HYDROCOLLOID DRESSING

K952071 · Sherwood Medical Co. · Jun 1995

CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS

K950065 · Conmedcorp · Mar 1995

CUTIPLAST STERIL

K943363 · Beiersdorf, Inc. · Mar 1995

POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING

K942774 · The Kendal Co. · Jul 1994

CUTIFILM(R) FILM

K926399 · Beiersdorf, Inc. · Nov 1993

DEROYAL TRANSPARENT FILM DRESSIGN

K920796 · Deroyal Industries, Inc. · Jul 1992

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 K946292

Bioderm, Inc.

Wheaton, IL · US

GEORGE WORTHLEY

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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