510(k) · Cleared
ClearedInnovaMatrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Triad Life Sciences, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Oct 21, 2020 as substantially equivalent to K061711 (Cook Biotech, Inc., 2006) after a 306-day review. Its family tree reaches back 1 generation to 2006. 3 later devices descend from it.
- Decided
- Oct 21, 2020
- Review
- 306 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K061711 (2006). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK061711 Oasis Wound MatrixCook Biotech, Inc. · 2006
- This deviceK193552 InnovaMatrixTriad Life Sciences, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK241866 InnovaMatrix®FDConvatec Triad Life Sciences, LLC · 2024
- Descendant · cites it directly · 0 of its ownK213716 InnovaBurnTriad Life Sciences, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK210580 InnovaMatrix FSTriad Life Sciences, Inc. · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K061711 | Oasis Wound Matrix | Cook Biotech, Inc. | 2006 | — |
| 0 (this device) | K193552 | InnovaMatrix | Triad Life Sciences, Inc. | 2020 | — |
| +1 | K241866 | InnovaMatrix®FD | Convatec Triad Life Sciences, LLC | 2024 | — |
| +1 | K213716 | InnovaBurn | Triad Life Sciences, Inc. | 2022 | — |
| +1 | K210580 | InnovaMatrix FS | Triad Life Sciences, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 KGN? 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 KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 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 |
|---|---|---|---|
| * | K061711 | Oasis Wound MatrixSummary page 4…ng Classification Regulation/Class: Unclassified Product Code: KGN Panel: General and Plastic Surgery 3. PREDICATE DEVICE Predicate Device: Oasis Wound Matrix (K061711) 4. DEVICE DESCRIPTION Description InnovaMatrix™ is a decellularized extracellular matrix (ECM) topical wound covering… | 2006 |
What descends from it? (3)
3 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?
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, 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 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
What is it indicated for?
InnovaMatrix™ is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.
The device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193552: InnovaMatrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193552
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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