# K023778: Dressskin

- Pathway: 510(k) (Abbreviated)
- Applicant: Tei Biosciences, Inc.
- Decided: Sep 29, 2003 after 321 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: 3 generations back to K881854 (1988). 8 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993948: Sis Wound Dressing II, Cook Biotech, Inc. (2000) Summary page 1.
- K982597: Fibrcol Plus Collagen Wound Dressing with Alginate, Johnson & Johnson Medical, Inc. (1998) Summary page 1.

## Most influential descendants
- K061407: Primatrix Dermal Repair Scaffold (2006), 27 descendants of its own
- K083440: Primatrix Dermal Repair Scaffold (2008), 20 descendants of its own
- K100261: Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold (2010), 6 descendants of its own
- K132343: Marigen Wound Dressing (2013), 5 descendants of its own
- K131286: Primatrix Dermal Repair Scaffold (2013), 5 descendants of its own

## Indications for use
Dressskin is intended for the management of wounds that include: Partial and full thickness wounds Pressure, diabetic, and venous ulcers Second-degree burns Surgical wounds-donor sites/grafts, post-moh’s surgery, post-laser surgery, podiatric, wound dehiscence Trauma wounds-abrasions, lacerations, and skin tears Tunneled/undermined wounds Draining wounds

Source page: https://510kreport.com/device/K023778
Methodology: https://510kreport.com/methodology