# K120250: Fibrillar Collagen Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Collafirm, LLC
- Decided: Apr 21, 2013 after 450 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 K910944 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910944: Medifil, Biocore (1991) Summary page 2.
- K012990: Collatek Powder, Biocore Medical Technologies, Inc. (2001) Summary page 2.

## Indications for use
CollaFirm Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including; pressure ulcers, diabetic ulcers, ulcers caused by mixed vascular origin- venous ulcers, donor and graft sites, abrasions, traumatic wounds healing by secondary intention, dehisced surgical wounds, first and second degree burns.

Source page: https://510kreport.com/device/K120250
Methodology: https://510kreport.com/methodology