# K141382: Bios King Biocellulose Film

- Pathway: 510(k) (Traditional)
- Applicant: Coreleader Biotech Co., Ltd.
- Decided: Feb 10, 2015 after 259 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950621 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950621: Biofill Biocellulose Dressing Sterile, The Purdue Frederick Co. (1995) Summary page 4.
- K974251: X-Cell Wound Dressing, Xylos Corporation (1998) Summary page 4.

## Indications for use
Bios King Biocellulose Film is indicated as a topical dressing to manage pressure sores, diabetic ulcers, 1st to 2nd degree burns and skin donor sites.

Source page: https://510kreport.com/device/K141382
Methodology: https://510kreport.com/methodology