510(k) · Cleared
ClearedTT101, Models TT 101-1,-2,-3,-4,-5,-6,-7,-8
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 Jul 3, 2006 as substantially equivalent to K014129 (Johnson & Johnson Medical, Ltd., 2002) after a 77-day review. Its family tree reaches back 3 generations to 1988. 4 later devices descend from it.
- Decided
- Jul 3, 2006
- Review
- 77 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K881854 (1988). 5 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 2 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 1 generation backK014129 Promogran Matrix Wound DressingJohnson & Johnson Medical, Ltd. · 2002
- This deviceK061060 TT101, Models TT 101-1,-2,-3,-4,-5,-6,-7,-8Tissue Technologies Holdings, LLC · 2006
- Descendant · cites it directly · 2 of its ownK070557 MP 719Marine Polymer Technologies, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK111524 MP 719Marine Polymer Technologies, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK102002 TalymedMarine Polymer Technologies · 2010
- Descendant · cites it directly · 0 of its ownK081246 TT-102Tissue Technologies Holdings, LLC · 2009
Most influential descendants
Showing 4 of 4 · See all- K070557MP 719Marine Polymer Technologies, Inc. · 2007 · cites it directly2descendants
- K111524MP 719Marine Polymer Technologies, Inc. · 2011 · 2 generations on0descendants
- K102002TalymedMarine Polymer Technologies · 2010 · 2 generations on0descendants
- K081246TT-102Tissue Technologies Holdings, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −2 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −1 | K014129 | Promogran Matrix Wound Dressing | Johnson & Johnson Medical, Ltd. | 2002 | — |
| 0 (this device) | K061060 | TT101, Models TT 101-1,-2,-3,-4,-5,-6,-7,-8 | Tissue Technologies Holdings, LLC | 2006 | — |
| +1 | K070557 | MP 719 | Marine Polymer Technologies, Inc. | 2007 | — |
| +2 | K111524 | MP 719 | Marine Polymer Technologies, Inc. | 2011 | — |
| +2 | K102002 | Talymed | Marine Polymer Technologies | 2010 | — |
| +1 | K081246 | TT-102 | Tissue Technologies Holdings, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (1)
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 |
|---|---|---|---|
| * | K014129 | Promogran Matrix Wound DressingSummary page 1…lO1 Wound Care Dressing Substantial Equivalence: TTLO1I Wound Care Dressing is substantially equivalent to: PROMOGRAN Matrix Wound Dressing (K014129) manufactured by Johnson & Johnson Medical Ltd., Gargrave, North Yorkshire, BD23 3RX, United Kingdom… | 2002 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K070557 (Marine Polymer Technologies, Inc., 2007) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K014129.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 T1101 Wound Care Dressing is indicated for the
management of exuding wounds including:
Diabetic ulcers
Venous ulcers
Ulcers caused by mixed vascular etiologies
Full thickness and partial thickness wounds
Donor sites and other bleeding surface wounds
Abrasions
Traumatic wounds healing by secondary intention
Dehisced surgical wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061060 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061060: TT101, Models TT 101-1,-2,-3,-4,-5,-6,-7,-8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061060
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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