Cleared Traditional

BTF THIN FILM WOUND DRESSING (K982939) - FDA 510(k) Clearance

K982939 · Bioderm, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
53d
Days
-
Risk

K982939 is an FDA 510(k) clearance for the BTF THIN FILM WOUND DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Bioderm, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on October 13, 1998 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 Bioderm, Inc. devices

Submission Details

510(k) Number K982939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1998
Decision Date October 13, 1998
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
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 MGP Dressing, Wound And Burn, Occlusive
Device Class -