Cleared Traditional

K982939 - BTF THIN FILM WOUND DRESSING

K982939 · Bioderm, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K982939

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
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 57
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K982939.
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013
K974891 · Acutek Adhesive Specialties, Inc. · Oct 1998
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
K974890 · Acutek Adhesive Specialties, Inc. · Oct 1998
ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012
K974892 · Acutek Adhesive Specialties, Inc. · Oct 1998
CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0
K981713 · Smith & Nephew, Inc. · Jul 1998
INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING
K981753 · Innovative Technologies , Ltd. · Jun 1998
SIMPLICARE THIN FILM WOUND DRESSINGS
K980209 · Hollister, Inc. · Feb 1998