# K901369: Green Label Biobrane II and Red Label Biobrane II

- Pathway: 510(k) (Traditional)
- Applicant: Sterling Drug, Inc.
- Decided: Jun 5, 1990 after 74 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K242146: BIOBRANE Temporary Wound Dressing; BIOBRANE Glove (2024), 0 descendants of its own
- K212579: FortiShield (Biosynthetic Wound Matrix) (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K901369
Methodology: https://510kreport.com/methodology