# K913023: Skintemp

- Pathway: 510(k) (Traditional)
- Applicant: Biocore
- Decided: Oct 2, 1991 after 85 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.
240 later devices descend from it; 3 cite it directly.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993948: Sis Wound Dressing II (2000), 235 descendants of its own
- K001738: Depuy Restore Orthobiologic Soft Tissue Implant (2000), 173 descendants of its own
- K020049: Fortaflex Surgical Mesh (2002), 102 descendants of its own
- K031969: Depuy Restore Orthobiologic Soft Tissue Implant (2003), 91 descendants of its own
- K042809: Cuffpatch (2004), 72 descendants of its own

Source page: https://510kreport.com/device/K913023
Methodology: https://510kreport.com/methodology