# K082869: Awbat-S, Awbat-D, Awbat-M

- Pathway: 510(k) (Traditional)
- Applicant: Aubrey, Inc.
- Decided: Feb 6, 2009 after 130 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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) Biobrane®: named in the summary without a submission number

## Most influential descendants
- K091863: Awbat-S Plus, Awbat-D Plus, Awbat-M Plus (2010), 2 descendants of its own
- K153678: PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove (2016), 1 descendant of its own
- K212579: FortiShield (Biosynthetic Wound Matrix) (2023), 0 descendants of its own

## Indications for use
AWBAT-S is intended for clean Superfical burn wounds. AWBAT-D is intended for Donor sites after hemostasis has been established. AWBAT-M is to be used as protective covering for Meshed autografts.

Source page: https://510kreport.com/device/K082869
Methodology: https://510kreport.com/methodology