510(k) · Cleared
ClearedKerecis SurgiBind (50241)
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 Jul 15, 2025 as substantially equivalent to K202430 (Kerecis Limited, 2021) after a 29-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Jul 15, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- OXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K921895 (1992). 30 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 8 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 7 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 6 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 5 generations backK992159 Surgisis SlingCook Biotech, Inc. · 1999
- 4 generations backK050337 Sis Fistula PlugCook Biotech, Inc. · 2005
- 3 generations backK161221 Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal…Cook Biotech Incorporated · 2016
- 2 generations backK191696 Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign…Cook Biotech Incorporated · 2019
- 1 generation backK202430 Kerecis ReconstructKerecis Limited · 2021
- This deviceK251844 Kerecis SurgiBind (50241)Kerecis Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −7 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −6 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −5 | K992159 | Surgisis Sling | Cook Biotech, Inc. | 1999 | — |
| −4 | K050337 | Sis Fistula Plug | Cook Biotech, Inc. | 2005 | — |
| −3 | K161221 | Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug | Cook Biotech Incorporated | 2016 | — |
| −2 | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery… | Cook Biotech Incorporated | 2019 | — |
| −1 | K202430 | Kerecis Reconstruct | Kerecis Limited | 2021 | — |
| 0 (this device) | K251844 | Kerecis SurgiBind (50241) | 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 |
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
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 |
|---|---|---|---|
| * | K202430 | Kerecis ReconstructSummary page 5…urgical Mesh Predicate Device Company Name: Kerecis Device Name (Proprietary): Kerecis Reconstruct Device 510(k): K202430 Reference Device Company Name: Cook Biotech Inc. Device Names (Proprietary): Biodesign Anal Fist… | 2021 |
| † | K191696 | Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix… | 2019 |
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 33 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 30 ancestors has a recall.
- 2 other devices also cite its predicate K202430.
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. 2025, 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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K251844 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251844: Kerecis SurgiBind (50241).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251844
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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