510(k) · Cleared
ClearedMP 719
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marine Polymer Technologies, Inc. · FRO Dressing, Wound, Drug
Cleared on May 23, 2007 as substantially equivalent to K984177 (Marine Polymer Technologies, Inc., 1998) and 4 other predicates after an 85-day review. Its family tree reaches back 4 generations to 1988. 2 later devices descend from it.
- Decided
- May 23, 2007
- Review
- 85 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K881854 (1988). 13 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- 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 backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 1 generation backK023778 DressskinTei Biosciences, Inc. · 2003
- This deviceK070557 MP 719Marine Polymer Technologies, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK111524 MP 719Marine Polymer Technologies, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK102002 TalymedMarine Polymer Technologies · 2010
Most influential descendants
Showing 2 of 2 · See allView 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 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −1 | K023778 | Dressskin | Tei Biosciences, Inc. | 2003 | — |
| 0 (this device) | K070557 | MP 719 | Marine Polymer Technologies, Inc. | 2007 | — |
| +1 | K111524 | MP 719 | Marine Polymer Technologies, Inc. | 2011 | — |
| +1 | K102002 | Talymed | Marine Polymer Technologies | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K984177 | Modification to SkvekpatchSummary page 1…er/ Name: Unclassified G. Regulatory Class; H. Product Code; FRO L Predicate Devices: Marine Polymer Technologies, Inc.- SyvekPatch (K(984177) and Sy-vekNT(K022673) Marine Polymer Technologies, Inc. -. RJ)H Bandage (K002550) Tissue Technologies Holdings LLC - TTIOI… | 1998 |
| Kept off the family tree | K022673 | Sy-vekNT Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…sified G. Regulatory Class; H. Product Code; FRO L Predicate Devices: Marine Polymer Technologies, Inc.- SyvekPatch (K(984177) and Sy-vekNT(K022673) Marine Polymer Technologies, Inc. -. RJ)H Bandage (K002550) Tissue Technologies Holdings LLC - TTIOI Wound Care Dressing (… | |
| * | K002550 | RDH BandageSummary page 1…FRO L Predicate Devices: Marine Polymer Technologies, Inc.- SyvekPatch (K(984177) and Sy-vekNT(K022673) Marine Polymer Technologies, Inc. -. RJ)H Bandage (K002550) Tissue Technologies Holdings LLC - TTIOI Wound Care Dressing (106 1060) TEI Biosciences Inc. Dress Skin (K(023 778) J&J… | 2000 |
| * | K061060 | TT101, Models TT 101-1,-2,-3,-4,-5,-6,-7,-8 | 2006 |
| * | K023778 | Dressskin | 2003 |
| * | K014129 | Promogran Matrix Wound Dressing | 2002 |
What descends from it? (2)
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 19 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K111524 (Marine Polymer Technologies, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K984177.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
TALIDERM Tm is indicated for the management of wounds including:
Diabetic ulcers
Venous ulcers
Pressure wounds
Ulcers caused by mixed vascular etiologies
Full thickness and partial thickness wounds
Second degree burns
Surgical wounds-donor sites/grafts, post-mohr's surgery, and other bleeding surface wounds
Abrasions
Traumatic wounds healing by secondary intention
Dehisced surgical wounds.
TALIDERM Tm is intended for use under the direction of a healthcare professional,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070557 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070557: MP 719.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070557
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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