510(k) · Cleared
ClearedKerecis SecureMesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kerecis Limited · OXE Mesh, Surgical, Collagen, Staple Line Reinforcement
Cleared on Aug 19, 2016 as substantially equivalent to K041669 (Synovis Surgical Innovations, 2004) and 1 other predicate after a 273-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Aug 19, 2016
- Review
- 273 days
- Class
- Class II
- Product code
- OXE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K921895 (1992). 70 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 backK043366 Permacol Surgical ImplantTissue Science Laboratories, Plc · 2004
- 4 generations backK050355 Permacol Surgical Implant T-Piece, Permacol Surgical Implant…Tissue Science Laboratories, Plc · 2005
- 3 generations backK070560 LRTM Surgical MeshLifecell Corp. · 2007 · Recalled
- 2 generations backK082103 LTM Wound DressingLifecell Corp. · 2008
- 1 generation backK132343 Marigen Wound DressingKerecis Limited · 2013
- This deviceK153364 Kerecis SecureMeshKerecis Limited · 2016
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 | K043366 | Permacol Surgical Implant | Tissue Science Laboratories, Plc | 2004 | — |
| −4 | K050355 | Permacol Surgical Implant T-Piece, Permacol Surgical Implant Rectocele-Piece… | Tissue Science Laboratories, Plc | 2005 | — |
| −3 | K070560 | LRTM Surgical Mesh | Lifecell Corp. | 2007 | 2 |
| −2 | K082103 | LTM Wound Dressing | Lifecell Corp. | 2008 | — |
| −1 | K132343 | Marigen Wound Dressing | Kerecis Limited | 2013 | — |
| 0 (this device) | K153364 | Kerecis SecureMesh | Kerecis Limited | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 2 | 0 |
| 2000 | 8 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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 OXE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K041669 | Veritas Dry Collagen Matrix, Veritas Dry or Veritas PSDSummary page 4…Mesh, Surgical Classification Product Code: OXE Regulatory Number: 878.3300 3 PREDICATE DEVICES Veritas Dry Collagen Matrix (K041669)- Primary Predicate MariGen Wound (K132343) - Supporting Predicate 4 DEVICE DESCRIPTION Subject Device is formed of… | 2004 |
| * | K132343 | Marigen Wound DressingSummary page 4…OXE Regulatory Number: 878.3300 3 PREDICATE DEVICES Veritas Dry Collagen Matrix (K041669)- Primary Predicate MariGen Wound (K132343) - Supporting Predicate 4 DEVICE DESCRIPTION Subject Device is formed of intact acellular fish skin and is intended to be used… | 2013 |
| † | K040415 | Peri-Strips Staple Line Reinforcement - Sleeve and Strip Configurations - and… | 2004 |
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 5 companies; a new generation was cleared every 2.8 years on median.
- 8 of the 70 ancestors have a recall of any class.
- 2 other devices also cite its predicate K041669.
How does its category compare?
All OXE devicesOXE Mesh, Surgical, Collagen, Staple Line Reinforcement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OXE
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OXE
Too few OXE 510(k)s in any year since 2007 to give a median.
Recalls per year · OXE
No recall names OXE since 2007.
Adverse event reports per year · OXE
No MAUDE report names OXE since 2007.
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 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Kerecis SecureMesh is intended for use as a prosthesis when staple line reinforcement is needed in surgical repair of soft tissue deficiencies using surgical staplers.
Kerecis SecureMesh can be used for reinforcement of staple lines during:
- Bariatric surgical procedures
- Colorectal and Colon surgical procedures
- Gastric, small bowels and mesentery procedures
- Lung and bronchus resections
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/K153364 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153364: Kerecis SecureMesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153364
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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