# K100574: Collexa

- Pathway: 510(k) (Traditional)
- Applicant: Innocoll Pharmaceuticals
- Decided: Oct 28, 2010 after 241 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.

## Cited in the summary but kept off the family tree
- K101299: Accu-Chek Aviva Plus Blood Glucose Monitoring System, Roche Diagnostics (2011). Our reading of the summary gave K101299, which FDA decided on Sep 21, 2011, after this device was decided (Oct 28, 2010), so it cannot be the predicate: a misreading, the summary’s own error, or a submission still pending at the time. Kept off the family tree. Summary page 1.

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

Source page: https://510kreport.com/device/K100574
Methodology: https://510kreport.com/methodology