# K012997: Collatek Foam

- Pathway: 510(k) (Traditional)
- Applicant: Biocore Medical Technologies, Inc.
- Decided: Oct 25, 2001 after 49 days
- Product code: MGP (Dressing, Wound And Burn, Occlusive)
- 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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) VigiFOAM: named in the summary without a submission number
- (no number) SkinTemp: named in the summary without a submission number

## Most influential descendants
- K080949: Keratec Wound Dressings (2009), 3 descendants of its own
- K162759: KeraStat (R) Gel (2017), 1 descendant of its own
- K192386: KeraStat Cream (2020), 0 descendants of its own
- K182010: ProgenaMatrix (2019), 0 descendants of its own

## Indications for use
Collatek Foam may be used in the management of Partial and full thickness wounds Pressure (stage 1-IV) and venous ulcers Ulcers caused by mixed vascular etiologies Venous stasis and diabetic ulcers 1st and 2nd degree burns Cuts, abrasions and surgical wounds

Source page: https://510kreport.com/device/K012997
Methodology: https://510kreport.com/methodology