510(k) · Cleared
ClearedMiromatrix Biological Mesh RS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Miromatrix Medical, Inc. · OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Cleared on May 12, 2015 as substantially equivalent to K134033 (Miromatrix Medical, Inc., 2014) after a 90-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- May 12, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- OXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921895 (1992). 7 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 1 generation backK134033 Miromatrix Biological MeshMiromatrix Medical, Inc. · 2014
- This deviceK150341 Miromatrix Biological Mesh RSMiromatrix Medical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK160400 Miromatrix Biological MeshMiromatrix Medical, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K160400Miromatrix Biological MeshMiromatrix Medical, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −3 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −1 | K134033 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | 2014 | — |
| 0 (this device) | K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | 2015 | — |
| +1 | 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 |
|---|---|---|
| 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 OXH? 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 OXH device
- #1 K202430 Kerecis Reconstructscore 12.1 · 7 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K134033 | Miromatrix Biological MeshSummary page 4…ruary 9, 2015 Classification Regulation: 21 CFR 878.3300, Class 11 Panel: General and Plastic Surgery Product Code: OXH Predicate Device: Miromatrix Biological Mesh (K134033) Indication for Use: The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in pa… | 2014 |
| † | K034039 | Sis Plastic Surgery Matrix | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160400 | Miromatrix Biological Mesh | 2016 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K160400 (Miromatrix Medical, Inc., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OXH devicesOXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OXH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OXH
Too few OXH 510(k)s in any year since 2007 to give a median.
Recalls per year · OXH
No recall names OXH since 2007.
Adverse event reports per year · OXH
2in 2025
MAUDE reports naming product code OXH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 21 |
| 2017 | 1 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150341: Miromatrix Biological Mesh RS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150341
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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