510(k) · Cleared
ClearedKerecis Reconstruct
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerecis Limited · OXH Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Cleared on May 2, 2021 as substantially equivalent to K191696 (Cook Biotech Incorporated, 2019) after a 250-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- May 2, 2021
- Review
- 250 days
- Class
- Class II
- Product code
- OXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K921895 (1992). 29 ancestors in all, the oldest K830889 (1983). 3 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 6 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 5 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 4 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 3 generations backK050337 Sis Fistula PlugCook Biotech, Inc. · 2005
- 2 generations backK161221 Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal…Cook Biotech Incorporated · 2016
- 1 generation backK191696 Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign…Cook Biotech Incorporated · 2019
- This deviceK202430 Kerecis ReconstructKerecis Limited · 2021
- Descendant · cites it directly · 0 of its ownK251844 Kerecis SurgiBind (50241)Kerecis Limited · 2025
- Descendant · cites it directly · 0 of its ownK251224 Restrata Soft Tissue Reinforcement (STR)Acera Surgical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK243843 Tendon Protect (50242)Kerecis Limited · 2025
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 |
|---|---|---|---|---|---|
| −7 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −6 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −5 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −4 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −3 | K050337 | Sis Fistula Plug | Cook Biotech, Inc. | 2005 | — |
| −2 | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | Cook Biotech Incorporated | 2016 | — |
| −1 | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery… | Cook Biotech Incorporated | 2019 | — |
| 0 (this device) | K202430 | Kerecis Reconstruct | Kerecis Limited | 2021 | — |
| +1 | K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | 2025 | — |
| +1 | K251224 | Restrata Soft Tissue Reinforcement (STR) | Acera Surgical, Inc. | 2025 | — |
| +1 | K243843 | Tendon Protect (50242) | Kerecis Limited | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 3 | 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 K251844 Kerecis SurgiBind (50241)score 11.8 · 8 generations · no Class I recall
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 |
|---|---|---|---|
| * | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix…Summary page 4…ompany Name: Cook Biotech Inc. Device Name (proprietary): Biodesign Plastic Surgery Matrix Device 510(k): K191696 (K161221, KO34039) Reference Device #1 Company Name: Kerecis Device Name (proprietary):… | 2019 |
| † | K153364 | Kerecis SecureMesh | 2016 |
| † | K133306 | Sis Hernia Graft | 2014 |
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 29 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 29 ancestors has a recall.
- Of its descendants, K251844 (Kerecis Limited, 2025) 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. 2021, 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 subject device is indicated for:
For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202430: Kerecis Reconstruct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202430
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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