510(k) · Cleared
ClearedRelimesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Herniamesh S.R.L. · FTL Mesh, Surgical, Polymeric
Cleared on Jun 19, 2008 as substantially equivalent to K971745 (Davol Inc., Sub. C. R. Bard, Inc., 1997) and 1 other predicate after a 38-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Jun 19, 2008
- Review
- 38 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K921895 (1992). 42 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 backK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
- 3 generations backK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
- 2 generations backK043259 Bioblanket Surgical MeshKensey Nash Corp. · 2005
- 1 generation backK070625 Pelvimesh / Hermesh 7Marketing Solutions, Inc. · 2007
- This deviceK081327 RelimeshHerniamesh S.R.L. · 2008
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 | K001738 | Depuy Restore Orthobiologic Soft Tissue Implant | DePuy Orthopaedics, Inc. | 2000 | — |
| −3 | K020049 | Fortaflex Surgical Mesh | Organogenesis, Inc. | 2002 | — |
| −2 | K043259 | Bioblanket Surgical Mesh | Kensey Nash Corp. | 2005 | — |
| −1 | K070625 | Pelvimesh / Hermesh 7 | Marketing Solutions, Inc. | 2007 | — |
| 0 (this device) | K081327 | Relimesh | Herniamesh S.R.L. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 8 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 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 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 |
|---|---|---|---|
| * | K971745 | Bard Composite ProsthesisSummary page 1…8 Orange Dr. Jericho, NY 11753 Tel 516 987-9364 Fax 516 938-2751 Device Name: Relimesh Predicate Devices: K971745 Composite Mesh (C.R. Bard Inc.) K070625 Hermesh 7 (Hemiamesh Sri) Device Description: Relimesh prostheses… | 1997 |
| * | K070625 | Pelvimesh / Hermesh 7Summary page 1…Tel 516 987-9364 Fax 516 938-2751 Device Name: Relimesh Predicate Devices: K971745 Composite Mesh (C.R. Bard Inc.) K070625 Hermesh 7 (Hemiamesh Sri) Device Description: Relimesh prostheses are dual component meshes made of non-absorbable… | 2007 |
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 16 years and passes through 7 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 42 ancestors have a recall of any class.
- 2 other devices also cite its predicate K971745.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies such as but not limited to hernia repairs and chest wall defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081327: Relimesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081327
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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