# K935189: E-Z Derm Biosynthetic Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Brennen Medical, Inc.
- Decided: Jul 11, 1994 after 258 days
- Product code: KGN (Wound Dressing With Animal-Derived Material(S))
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K020732: SS Matrix (2002), 5 descendants of its own
- K061474: Collawound Dressing (2006), 3 descendants of its own
- K090894: Collawound Wound Dressing (2009), 2 descendants of its own
- K162348: ABCcolla Collagen Matrix (2017), 1 descendant of its own
- K233378: ABCcolla® Collagen ADM Scaffold (2024), 0 descendants of its own

## Recalls of this device
- Mar 26, 2019 · Class II · Z-1243-2019: Intermittent heat seal failures on the outer pouch of some EZ Derm products.

Source page: https://510kreport.com/device/K935189
Methodology: https://510kreport.com/methodology