# K103648: Collagen Powder

- Pathway: 510(k) (Traditional)
- Applicant: Innocoll Pharmaceuticals, Ltd.
- Decided: Sep 14, 2011 after 274 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: 7 generations back to K910944 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092805: Collagen Sponge, Innocoll Pharmaceuticals (2010) Summary page 1.
- K012990: Collatek Powder, Biocore Medical Technologies, Inc. (2001)

## Indications for use
Collagen Powder may be used for the management of wounds such as: Diabetic ulcers Venous ulcers Pressure ulcers Ulcers caused by mixed vascular etiologies Full- & partial thickness wounds Abrasions Traumatic wounds 1st and 2nd degree burns Dehisced surgical wounds Exuding wounds

Source page: https://510kreport.com/device/K103648
Methodology: https://510kreport.com/methodology