# K112580: Collagen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Dalim Tissen Co., Ltd.
- Decided: Jun 1, 2012 after 269 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
Longest line of descent: 6 generations back to K881854 (1988). 11 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090812: Theraform Standard/Sheet, Sewon Cellontech Co., Ltd. (2009) Summary page 2.

## Most influential descendants
- K182725: Apis (2019), 2 descendants of its own
- K222143: Apis (R), Veris (TM) (2023), 0 descendants of its own
- K211972: Omeza Collagen Matrix (2021), 0 descendants of its own
- K140456: Bio-Connekt Wound Matrix (2014), 0 descendants of its own

## Indications for use
Collagen Wound Dressing is intended use for management of partial and full-thickness wounds including: pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers, tunneled / undermined wounds, surgical wound (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree bums, and skin tears), draining wounds.

Source page: https://510kreport.com/device/K112580
Methodology: https://510kreport.com/methodology