# K982939: BTF Thin Film Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Bioderm, Inc.
- Decided: Oct 13, 1998 after 53 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
20 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Smith & Nephew, OpSite: named in the summary without a submission number
- (no number) 3M, Tegaderm Transparent Dressing: named in the summary without a submission number
- (no number) Hollister, Simplicare Thin Film Wound Dressing: named in the summary without a submission number
- (no number) J & J, Bioclusive MVP Transparent Dressing: named in the summary without a submission number
- (no number) Innovative Technologies, Transparent Thin Film and Intelligent Thin Film Wound Dressing: named in the summary without a submission number

## Most influential descendants
- K031684: Topkin Wound Dressing (2003), 19 descendants of its own
- K090160: Suprathel Wound and Burn Dressing (2009), 18 descendants of its own
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- K142879: BTM Wound Dressing (2015), 5 descendants of its own
- K172140: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (2017), 4 descendants of its own

## Indications for use
The BioDerm BTF Wound Dressing is a sterile thin film dressing intended for over-the-counter use and prescription use. The BioDerm BTF consists of a transparent, polyurethane film backed with a hypoallergenic pressure sensitive adhesive. The BTF is permeable to moisture vapor and oxygen and intended to maintain a moist wound healing environment. A moist wound environment allows atolytic debridement. OTC Indications for Use: Abrasions, lacerations, minor/superficial cuts; Minor scalds, minor burns; Minor irritations to the skin Under the Care of a Health Care Professional: Leg ulcers, pressure ulcers (stages I and II); Surgical wounds (post operative wounds, donor sites); 1 and 2" degree burns; Cover and protect catheter sites and wounds; Securement of medical appliances; Catheter securing device; Dermal lesions; Non-exuding to minimally exuding wounds

Source page: https://510kreport.com/device/K982939
Methodology: https://510kreport.com/methodology