510(k) · Cleared
ClearedTT-102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tissue Technologies Holdings, LLC · FRO Dressing, Wound, Drug
Cleared on Aug 13, 2009 as substantially equivalent to K061060 (Tissue Technologies Holdings, LLC, 2006) and 1 other predicate after a 469-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Aug 13, 2009
- Review
- 469 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K881854 (1988). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 3 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 2 generations backK014129 Promogran Matrix Wound DressingJohnson & Johnson Medical, Ltd. · 2002
- 1 generation backK061060 TT101, Models TT 101-1,-2,-3,-4,-5,-6,-7,-8Tissue Technologies Holdings, LLC · 2006
- This deviceK081246 TT-102Tissue Technologies Holdings, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −3 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −2 | K014129 | Promogran Matrix Wound Dressing | Johnson & Johnson Medical, Ltd. | 2002 | — |
| −1 | K061060 | TT101, Models TT 101-1,-2,-3,-4,-5,-6,-7,-8 | Tissue Technologies Holdings, LLC | 2006 | — |
| 0 (this device) | K081246 | TT-102 | Tissue Technologies Holdings, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K061060 | TT101, Models TT 101-1,-2,-3,-4,-5,-6,-7,-8Summary page 1…''F Wound Dressing is substantially equivalent to: TT-101 Wound Care Dressing (K 061060) Manufactured by an FDA registered contract manuf… | 2006 |
| * | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…Summary page 1…Manufactured by an FDA registered contract manufacturer AQUACEL® Ag with Hydrofiber (K063271) Manufactured by ConvaTec, A division of E. R. Squibb… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K061060.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081246 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081246: TT-102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081246
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026