510(k) · Cleared
ClearedMiro3D Wound Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reprise Biomedical · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Nov 21, 2022 as substantially equivalent to K221520 (Reprise Biomedical, Inc., 2022) after a 31-day review. Its family tree reaches back 3 generations to 2006. 3 later devices descend from it.
- Decided
- Nov 21, 2022
- Review
- 31 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K061711 (2006). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK061711 Oasis Wound MatrixCook Biotech, Inc. · 2006
- 2 generations backK140510 Miromatrix Wound MatrixMiromatrix Medical, Inc. · 2014
- 1 generation backK221520 Miro3D Wound MatrixReprise Biomedical, Inc. · 2022
- This deviceK223257 Miro3D Wound MatrixReprise Biomedical · 2022
- Descendant · cites it directly · 0 of its ownK240753 Miro3D Fibers Wound MatrixReprise Biomedical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK240277 MiroDry Wound MatrixReprise Biomedical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK231614 MiroTract Wound MatrixReprise Biomedical, Inc. · 2023
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 |
|---|---|---|---|---|---|
| −3 | K061711 | Oasis Wound Matrix | Cook Biotech, Inc. | 2006 | — |
| −2 | K140510 | Miromatrix Wound Matrix | Miromatrix Medical, Inc. | 2014 | — |
| −1 | K221520 | Miro3D Wound Matrix | Reprise Biomedical, Inc. | 2022 | — |
| 0 (this device) | K223257 | Miro3D Wound Matrix | Reprise Biomedical | 2022 | — |
| +1 | K240753 | Miro3D Fibers Wound Matrix | Reprise Biomedical, Inc. | 2024 | — |
| +1 | K240277 | MiroDry Wound Matrix | Reprise Biomedical, Inc. | 2024 | — |
| +1 | K231614 | MiroTract Wound Matrix | Reprise Biomedical, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K221520 | Miro3D Wound MatrixSummary page 4…lassified Product Code: KGN Panel: General & Plastic Surgery III. PREDICATE DEVICE Miro3D Wound Matrix, K221520 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.… | 2022 |
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?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 7.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K240753 (Reprise Biomedical, Inc., 2024) has gone furthest, with 0 descendants of its own.
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. 2022, 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?
The Miro3D Wound Matrix is indicated for the following:
The Miro3D Wound Matrix is intended for the management of wounds including:
• Partial and full thickness wounds
• Pressure ulcers
• Venous ulcers
• Chronic vascular ulcers
• Diabetic ulcers
• Tunneled, undermined wounds
• Trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
• Draining wounds
• Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223257 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223257: Miro3D Wound Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223257
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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