510(k) · Cleared
ClearedMiromatrix Biological Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miromatrix Medical, Inc. · FTM Mesh, Surgical
Cleared on Mar 31, 2014 as substantially equivalent to K980431 (Cook Biotech, Inc., 1998) after a 90-day review. Its family tree reaches back 3 generations to 1992. 2 later devices descend from it.
- Decided
- Mar 31, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- FTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921895 (1992). 6 ancestors in all, the oldest K830889 (1983). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 2 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 1 generation backK980431 SurgisisCook Biotech, Inc. · 1998
- This deviceK134033 Miromatrix Biological MeshMiromatrix Medical, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK150341 Miromatrix Biological Mesh RSMiromatrix Medical, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK160400 Miromatrix Biological MeshMiromatrix Medical, Inc. · 2016
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 |
|---|---|---|---|---|---|
| −3 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −2 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −1 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| 0 (this device) | K134033 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | 2014 | — |
| +1 | K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | 2015 | — |
| +2 | K160400 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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 FTM? 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 FTM device
- #1 K262406 EluPro Antibiotic-Eluting BioEnvelopescore 15.1 · 12 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 |
|---|---|---|---|
| * | K980431 | SurgisisSummary page 1…fication Regulation: 21 CFR 878.3300 Panel: General & Plastic Surgery Product Code: FTM Predicate Device: K98043 1, SurgiSiS Surgical Mesh Cook Biotech, Inc. CONFIDENTIAL… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150341 | Miromatrix Biological Mesh RS | 2015 | 1 |
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 22 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K150341 (Miromatrix Medical, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 28 other devices also cite its predicate K980431.
How does its category compare?
All FTM devicesFTM Mesh, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FTM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTM
29in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTM
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTM
232in 2025
MAUDE reports naming product code FTM, 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 | 9 | 104 | 7 | 60 |
| 2008 | 9 | 86 | 1 | 141 |
| 2009 | 7 | 86 | 0 | 476 |
| 2010 | 2 | — | 1 | 197 |
| 2011 | 6 | 100 | 8 | 288 |
| 2012 | 4 | 66 | 0 | 467 |
| 2013 | 4 | 123 | 0 | 3,351 |
| 2014 | 8 | 153 | 0 | 1,093 |
| 2015 | 4 | 316 | 0 | 977 |
| 2016 | 7 | 88 | 0 | 509 |
| 2017 | 9 | 147 | 0 | 529 |
| 2018 | 2 | — | 21 | 357 |
| 2019 | 6 | 107 | 4 | 418 |
| 2020 | 4 | 59 | 1 | 457 |
| 2021 | 4 | 61 | 1 | 369 |
| 2022 | 0 | — | 0 | 375 |
| 2023 | 2 | — | 1 | 485 |
| 2024 | 3 | 29 | 0 | 383 |
| 2025 | 1 | — | 0 | 232 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134033 · printed Nov 4, 2026
Cite this page
510(k) Report. “K134033: Miromatrix Biological Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K134033
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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