Cleared Traditional

K990042 - SILON DUAL-DRESS

K990042 · Bio Med Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
72d
Days
-
Risk

K990042 is an FDA 510(k) clearance for the SILON DUAL-DRESS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Bio Med Sciences, Inc. (Bethlehem, US). The FDA issued a Cleared decision on March 19, 1999 after a review of 72 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 Bio Med Sciences, Inc. devices

FDA 510(k) Submission Details - K990042

510(k) Number K990042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1999
Decision Date March 19, 1999
Days to Decision 72 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 115d · This submission: 72d
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 293
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K990042.
ABSORBENT ANTIMICROBIAL WOUND DRESSING
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SILVERLON WOUND PACKING STRIPS
K984210 · Argentum International, LLC · Sep 1999
DUMEX IODOFORM PACKING STRIP
K990332 · Dumex Medical Surgical Products, Ltd. · Apr 1999
MODIFICATION OF CUTINOVA THIN DRESSING
K984593 · Beiersdorf-Jobt, Inc. · Mar 1999
MODIFICATION OF CUTINOVA HYDRO DRESSING
K984595 · Beiersdorf-Jobt, Inc. · Mar 1999
MODIFICATION OF CUTINOVA CAVITY DRESSING
K984597 · Beiersdorf-Jobt, Inc. · Mar 1999