# K122325: Skintemp II

- Pathway: 510(k) (Traditional)
- Applicant: Human Biosciences, Inc.
- Decided: Oct 26, 2012 after 86 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: 1 generation back to K913023 (1991). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913023: Skintemp, Biocore (1991) Summary page 3.
- K925545: Skintemp, Modification, Biocore (1993) Summary page 3.

## Most influential descendants
- K213092: Cellusheet, Cellufil (2021), 1 descendant of its own
- K253974: Roosin Collagen Dressing (2026), 0 descendants of its own
- K232758: Comatryx OTC (2023), 0 descendants of its own

## Indications for use
The device is intended for the management of bums, sores, blisters, scrapes, ulcers, and other wounds.

Source page: https://510kreport.com/device/K122325
Methodology: https://510kreport.com/methodology