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. · OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Cleared on Jun 8, 2016 as substantially equivalent to K150341 (Miromatrix Medical, Inc., 2015) after a 117-day review. Its family tree reaches back 5 generations to 1992.
- Decided
- Jun 8, 2016
- Review
- 117 days
- Class
- Class II
- Product code
- OXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921895 (1992). 8 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 5 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 4 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 3 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 2 generations backK134033 Miromatrix Biological MeshMiromatrix Medical, Inc. · 2014
- 1 generation backK150341 Miromatrix Biological Mesh RSMiromatrix Medical, Inc. · 2015
- This deviceK160400 Miromatrix Biological MeshMiromatrix Medical, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −4 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −3 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −2 | K134033 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | 2014 | — |
| −1 | K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | 2015 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K150341 | Miromatrix Biological Mesh RSSummary page 4…de: OXH and FTM Panel: General and Plastic Surgery 3. PREDICATE DEVICE Predicate Device: Miromatrix Biological Mesh (cleared as Miromatrix Biological Mesh RS), K150341 Reference Device: K134033, Miromatrix Biological Mesh 4. DEVICE DESCRIPTION The Miromatrix Biological Mesh is an implan… | 2015 |
| † | K134033 | Miromatrix Biological Mesh | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 8 ancestors has a recall.
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. 2016, 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 is intended to be implanted to reinforce soft tissue and is also intended 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 as stated in the FDA summary.
https://510kreport.com/device/K160400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160400: Miromatrix Biological Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160400
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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