510(k) · Cleared
ClearedGore Infinit Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W. L. Gore & Associates, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on May 30, 2008 as substantially equivalent to K992189 (W. L. Gore & Associates, Inc., 1999) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1999. 21 later devices descend from it.
- Decided
- May 30, 2008
- Review
- 45 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992189 (1999). 2 ancestors in all. 21 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK992189 Gore-Tex Dualmesh BiomaterialW. L. Gore & Associates, Inc. · 1999
- This deviceK081069 Gore Infinit MeshW. L. Gore & Associates, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK081777 Ventrio Hernia PatchC.R. Bard, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 13 of its ownK100229 Ventrio Hernia PatchC.R. Bard, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK152609 GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK113229 Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012
- Descendant · 2 generations on · 3 of its ownK101920 Ventrio ST Hernia PatchC.R. Bard, Inc. · 2011
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K081777Ventrio Hernia PatchC.R. Bard, Inc. · 2008 · cites it directly14descendants
- K100229Ventrio Hernia PatchC.R. Bard, Inc. · 2010 · 2 generations on13descendants
- K152609GORE SYNECOR BiomaterialW. L. Gore & Associates, Inc. · 2015 · cites it directly3descendants
- K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012 · 2 generations on3descendants
- K101920Ventrio ST Hernia PatchC.R. Bard, Inc. · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992189 | Gore-Tex Dualmesh Biomaterial | W. L. Gore & Associates, Inc. | 1999 | — |
| 0 (this device) | K081069 | Gore Infinit Mesh | W. L. Gore & Associates, Inc. | 2008 | — |
| +1 | K081777 | Ventrio Hernia Patch | C.R. Bard, Inc. | 2008 | 4 |
| +2 | K100229 | Ventrio Hernia Patch | C.R. Bard, Inc. | 2010 | — |
| +1 | K152609 | GORE SYNECOR Biomaterial | W. L. Gore & Associates, Inc. | 2015 | — |
| +2 | K113229 | Ventrio Light Hernia Patch with TRM Antimicrobial Coating | C.R. Bard, Inc. | 2012 | — |
| +2 | K101920 | Ventrio ST Hernia Patch | C.R. Bard, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K992189 | Gore-Tex Dualmesh BiomaterialSummary page 1…Product Code: FTL Class: II Substantial Equivalence: Predicate devices 1. Product Name: GORE DUALMESH® Biomaterial 510k #: K992189 Manufacturer: W.L. Gore & Associates, Inc.… | 1999 |
| * | K001122 | Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical MeshSummary page 2…INFINIT Mesh Section 5. 510(k) SUMMARY T 2. Product Name: Prolened Soft (Polypropylene) Mesh 510k #: K001122 Manufacturer: ETHICON, Inc. The GORE INFINIT Mesh is comprised of the same base material (PTFE) as the… | 2000 |
What descends from it? (21)
See all 213 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?
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?
GORE INFINIT Mesh is indicated for use in the reconstruction of hernias and other soft tissue deficiencies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081069 · printed Nov 3, 2026
Cite this page
510(k) Report. “K081069: Gore Infinit Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K081069
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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