# K012990: Collatek Powder

- Pathway: 510(k) (Traditional)
- Applicant: Biocore Medical Technologies, Inc.
- Decided: Oct 24, 2001 after 48 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.
65 later devices descend from it; 8 cite it directly.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) hyCURE® Powder: named in the summary without a submission number
- (no number) Comfeel® Powder: named in the summary without a submission number
- (no number) Medifil® Particles: named in the summary without a submission number

## Most influential descendants
- K030774: Stimulen Collagen (2004), 29 descendants of its own
- K030921: Collagen Topical Wound Dressing (2003), 28 descendants of its own
- K061494: Dermadapt Wound Dressing (2006), 26 descendants of its own
- K071425: Unite Biomatrix (2007), 25 descendants of its own
- K092096: Endoform Dermal Template (2010), 19 descendants of its own

## Indications for use
Collatek Powder may be used in the management of: Partial and full thickness wounds Pressure (stage I-1V) and venous ulcers Ulcers caused by mixed vascular etiologies Venous stasis and diabetic ulcers Ist and 2™ degree burns Cuts. abrasions and surgical wounds

Source page: https://510kreport.com/device/K012990
Methodology: https://510kreport.com/methodology