# K081246: TT-102

- Pathway: 510(k) (Traditional)
- Applicant: Tissue Technologies Holdings, LLC
- Decided: Aug 13, 2009 after 469 days
- Product code: FRO (Dressing, Wound, Drug)
- 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: 4 generations back to K881854 (1988). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061060: TT101, Models TT 101-1,-2,-3,-4,-5,-6,-7,-8, Tissue Technologies Holdings, LLC (2006) Summary page 1.
- K063271: Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated Antimicrobial Dressing, Convatec, A Division of E.R. Squibb & Sons, LLC (2007) Summary page 1.

## Indications for use
The TT-102 Wound Dressing is indicated for the management of: Diabetic ulcers Venous ulcers Pressure ulcers Ulcers caused by mixed vascular etiologies Full thickness and partial thickness wounds Traumatic wound healing by secondary intention Dehisced surgical wounds Abrasions Donor sites and other bleeding wounds

Source page: https://510kreport.com/device/K081246
Methodology: https://510kreport.com/methodology