# K896110: Biobrane (R) II

- Pathway: 510(k) (Traditional)
- Applicant: Sterling Drug, Inc.
- Decided: Nov 28, 1989 after 36 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- 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.
54 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021792: Bilayer Matrix Wound Dressing (2002), 53 descendants of its own
- K092096: Endoform Dermal Template (2010), 19 descendants of its own
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- K081635: Integra Meshed Bilayer Wound Matrix (2008), 10 descendants of its own
- K142879: BTM Wound Dressing (2015), 5 descendants of its own

Source page: https://510kreport.com/device/K896110
Methodology: https://510kreport.com/methodology