510(k) · Cleared
ClearedParietene Macroporous 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 Oct 17, 2014 as substantially equivalent to K001122 (ETHICON, Inc., 2000) and 1 other predicate after a 77-day review. Its family tree reaches back 7 generations to 1999. 2 later devices descend from it.
- Decided
- Oct 17, 2014
- Review
- 77 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K991400 (1999). 14 ancestors in all, the oldest K810428 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK991400 Parietene Polypropylene MeshSofradim Production · 1999
- 6 generations backK033376 Ugytex MeshSofradim Production · 2004
- 5 generations backK040998 Modification to Parietex Composite (Pco) MeshSofradim Production · 2004
- 4 generations backK073287 Prevadh MeshSofradim Production · 2008
- 3 generations backK081050 Parietex Progrip MeshSofradim Production · 2008
- 2 generations backK101197 Parie Tene Progrip MeshSofradim Production · 2010
- 1 generation backK140941 Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet MeshSofradim Production · 2014
- This deviceK142091 Parietene Macroporous MeshSofradim Production · 2014
- Descendant · cites it directly · 1 of its ownK223218 Parietene Macroporous MeshSofradim Production · 2022
- Descendant · cites it directly · 0 of its ownK250869 Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K991400 | Parietene Polypropylene Mesh | Sofradim Production | 1999 | — |
| −6 | K033376 | Ugytex Mesh | Sofradim Production | 2004 | — |
| −5 | K040998 | Modification to Parietex Composite (Pco) Mesh | Sofradim Production | 2004 | — |
| −4 | K073287 | Prevadh Mesh | Sofradim Production | 2008 | — |
| −3 | K081050 | Parietex Progrip Mesh | Sofradim Production | 2008 | — |
| −2 | K101197 | Parie Tene Progrip Mesh | Sofradim Production | 2010 | — |
| −1 | K140941 | Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet Mesh | Sofradim Production | 2014 | — |
| 0 (this device) | K142091 | Parietene Macroporous Mesh | Sofradim Production | 2014 | — |
| +1 | K223218 | Parietene Macroporous Mesh | Sofradim Production | 2022 | — |
| +1 | K250869 | Parietene™ Macroporous Mesh (PPM5050 ) | Sofradim Production | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1993 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K001122 | Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical MeshSummary page 4…TM which equivalence is claimed: PROLENE Soft (Polypropylene) Mesh (K001122) Parietene™ Flat Sheet Mesh (K140941)… | 2000 |
| * | K140941 | Progrip Self-Gripping Polypropylene Mesh, Parietene Flat Sheet MeshSummary page 4…which equivalence is claimed: PROLENE Soft (Polypropylene) Mesh (K001122) Parietene™ Flat Sheet Mesh (K140941) TM Reason for 510(k) submission: To obtain market c… | 2014 |
What descends from it? (2)
2 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 15 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K223218 (Sofradim Production, 2022) has gone furthest, with 1 descendant of its own.
- 12 other devices also cite its predicate K001122.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The Parietene™ Macroporous Mesh is intended for the repair of hernias or other fascial deficiencies that require the addition of a reinforcing material.
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/K142091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142091: Parietene Macroporous Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142091
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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