510(k) · Cleared
ClearedParietene Polypropylene 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 Jul 12, 1999 after an 81-day review. The FDA summary names its predicate without a number. 82 later devices descend from it.
- Decided
- Jul 12, 1999
- Review
- 81 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
82 later devices descend from it, 8 citing it directly.
- This deviceK991400 Parietene Polypropylene MeshSofradim Production · 1999
- Descendant · cites it directly · 70 of its ownK033376 Ugytex MeshSofradim Production · 2004
- Descendant · 2 generations on · 61 of its ownK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- Descendant · 3 generations on · 31 of its ownK050187 Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005
- Descendant · 2 generations on · 17 of its ownK073287 Prevadh MeshSofradim Production · 2008
- Descendant · 3 generations on · 15 of its ownK081126 Parietex Composite Mono PM MeshSofradim Production · 2008 · Recalled
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 82 · See all- K033376Ugytex MeshSofradim Production · 2004 · cites it directly70descendants
- K040998Modification to Parietex Composite (Pco) MeshSofradim Production · 2004 · 2 generations on61descendants
- K050187Parietex Composite Pco-OS and Pco-OB MeshesSofradim Production · 2005 · 3 generations on31descendants
- K073287Prevadh MeshSofradim Production · 2008 · 2 generations on17descendants
- K081126Parietex Composite Mono PM MeshSofradim Production · 2008 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| +1 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| +2 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| +3 | K050187 | Parietex Composite Pco-OS and Pco-OB Meshes | Sofradim Production | 2005 | — |
| +2 | K073287 | Prevadh Mesh | Sofradim Production | 2008 | — |
| +3 | K081126 | Parietex Composite Mono PM Mesh | Sofradim Production | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 9 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 7 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | — | Bard-Davol Visilex® Mesh Named without a submission number | |
| * | — | Atrium Medical Corporation Atrium® Mesh Named without a submission number | |
| * | — | Sofradim Parietex® Meshes Named without a submission number |
What descends from it? (82)
See all 828 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033376 | Ugytex Mesh | 2004 | 70 |
| K101197 | Parie Tene Progrip Mesh | 2010 | 6 |
| K140941 | Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet Mesh | 2014 | 5 |
| K041176 | Uretex to Trans-Obturator Urethral Support System | 2004 | 4 |
| K073579 | Dynamesh-PP Standard, Model PP02NNNN, Dynamesh-PP Light, Model PP01NNNN | 2008 | 3 |
| K073164 | Ivs Tunneller Devices | 2008 | 0 |
| K072951 | Parietene Duo and Quadra Polypropylene Meshes | 2007 | 0 |
| K012949 | Uretex Sup Pubourethral Sling | 2001 | 0 |
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?
- Of its descendants, K033376 (Sofradim Production, 2004) has gone furthest, with 70 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Parietene® Polypropylene Mesh is a polypropylene mesh intended for the reinforcement of tissue during surgical repair. It is indicated for inguinal heruiay, puietal reinforcement of tissues and abdominal wall hemia repair.
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/K991400 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991400: Parietene Polypropylene Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991400
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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