510(k) · Cleared
ClearedCovamesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomup S.A. · FTL Mesh, Surgical, Polymeric
Cleared on Oct 25, 2013 as substantially equivalent to K040998 (Sofradim Production, 2004) and 1 other predicate after a 247-day review. Its family tree reaches back 4 generations to 1985.
- Decided
- Oct 25, 2013
- Review
- 247 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K850785 (1985). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 3 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 2 generations backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- 1 generation backK103081 Covaortho-Nerve Resorbable Collagen MembraneBiom'Up Sas · 2012
- This deviceK130428 CovameshBiomup S.A. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −3 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −2 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| −1 | K103081 | Covaortho-Nerve Resorbable Collagen Membrane | Biom'Up Sas | 2012 | — |
| 0 (this device) | K130428 | Covamesh | Biomup S.A. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K040998 | Modification to Parietex Composite (Pco) MeshSummary page 1…mber: 21 CFR 878.3300 Device Classification: Class 11 Predicate Devices PARJETEX COMPOSITE Mesh (K040998) CovaTmORTHO NERVE (K 10308 1) Device Description COVAMESHTM is a surgical mesh u… | 2004 |
| * | K103081 | Covaortho-Nerve Resorbable Collagen MembraneSummary page 1…Class 11 Predicate Devices PARJETEX COMPOSITE Mesh (K040998) CovaTmORTHO NERVE (K 10308 1) Device Description COVAMESHTM is a surgical mesh used during open procedures (laparotomy) or during laparoscopic procedures.… | 2012 |
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 28 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 12 ancestors have a recall of any class.
- 12 other devices also cite its predicate K040998.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Intended for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-resorbable three dimensional polyester mesh provides long-term reinforcement of soft tissues.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130428: Covamesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130428
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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