510(k) · Cleared
ClearedPrevadh Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofradim Production · FTL Mesh, Surgical, Polymeric
Cleared on Mar 13, 2008 as substantially equivalent to K040998 (Sofradim Production, 2004) and 2 other predicates after a 113-day review. Its family tree reaches back 3 generations to 1999. 17 later devices descend from it.
- Decided
- Mar 13, 2008
- Review
- 113 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K991400 (1999). 6 ancestors in all, the oldest K810428 (1981). 17 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 2 generations backK033376 Ugytex MeshSofradim Production · 2004
- 1 generation backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- This deviceK073287 Prevadh MeshSofradim Production · 2008
- Descendant · cites it directly · 15 of its ownK081050 Parietex Progrip MeshSofradim Production · 2008
- Descendant · 2 generations on · 6 of its ownK103682 Parietex ProgripSofradim Production · 2011
- Descendant · 2 generations on · 6 of its ownK101519 Parietex Plug and PatchSofradim Production · 2010
- Descendant · 2 generations on · 6 of its ownK101197 Parie Tene Progrip MeshSofradim Production · 2010
- Descendant · 3 generations on · 5 of its ownK142900 Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester…Sofradim Production · 2014
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K081050Parietex Progrip MeshSofradim Production · 2008 · cites it directly15descendants
- K103682Parietex ProgripSofradim Production · 2011 · 2 generations on6descendants
- K101519Parietex Plug and PatchSofradim Production · 2010 · 2 generations on6descendants
- K101197Parie Tene Progrip MeshSofradim Production · 2010 · 2 generations on6descendants
- K142900Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug…Sofradim Production · 2014 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −2 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| −1 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| 0 (this device) | K073287 | Prevadh Mesh | Sofradim Production | 2008 | — |
| +1 | K081050 | Parietex Progrip Mesh | Sofradim Production | 2008 | — |
| +2 | K103682 | Parietex Progrip | Sofradim Production | 2011 | — |
| +2 | K101519 | Parietex Plug and Patch | Sofradim Production | 2010 | — |
| +2 | K101197 | Parie Tene Progrip Mesh | Sofradim Production | 2010 | — |
| +3 | K142900 | Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh)… | Sofradim Production | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2022 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (3)
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…Mesh COMMON/USUAL NAME: Surgical Mesh CLASSIFICATION NAME: Mesh, Surgical, Polymeric PREDICATE DEVICE(S): PARIETEX~ COMPOSITE (PCO) Mesh (K040998) Ethicon, Inc. VICRYL Mesh (K810428) UGYTEX TM Mesh (K033376) DEVIC… | 2004 |
| * | K810428 | VicrylSummary page 1…ME: Mesh, Surgical, Polymeric PREDICATE DEVICE(S): PARIETEX~ COMPOSITE (PCO) Mesh (K040998) Ethicon, Inc. VICRYL Mesh (K810428) UGYTEX TM Mesh (K033376) DEVICE DESCRIPTION: PREVADHW Mesh is sterile and can be ancho… | 1981 |
| * | K033376 | Ugytex MeshSummary page 1…(S): PARIETEX~ COMPOSITE (PCO) Mesh (K040998) Ethicon, Inc. VICRYL Mesh (K810428) UGYTEX TM Mesh (K033376) DEVICE DESCRIPTION: PREVADHW Mesh is sterile and can be anchored. It has three compone… | 2004 |
What descends from it? (17)
See all 172 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 9 years and passes through 1 company; a new generation was cleared every 3.9 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K081050 (Sofradim Production, 2008) has gone furthest, with 15 descendants of its own.
- 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. 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?
PREVADH mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073287: Prevadh Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073287
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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