# K012995: Collatek Sheet

- 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.
19 later devices descend from it; 1 cites it directly.
0 of 20 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) Cutinova® hydro: named in the summary without a submission number
- (no number) DuoDerm® Extra Thin: named in the summary without a submission number
- (no number) DuoDerm® CGF: named in the summary without a submission number
- (no number) hyCURE® sheet: named in the summary without a submission number

## Most influential descendants
- K090160: Suprathel Wound and Burn Dressing (2009), 18 descendants of its own
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- K142879: BTM Wound Dressing (2015), 5 descendants of its own
- K172140: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (2017), 4 descendants of its own
- K170300: Restrata Wound Matrix (2017), 4 descendants of its own

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

Source page: https://510kreport.com/device/K012995
Methodology: https://510kreport.com/methodology