510(k) · Cleared
ClearedBard 3DMAX Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321, 011732
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Aug 3, 2009 after a 55-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Aug 3, 2009
- Review
- 55 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK091659 Bard 3DMAX Light Mesh, Models: 0117310, 0117311, 0117312, 0117320…C.R. Bard, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK142711 ONFLEX MeshC.R. Bard, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK251955 Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK200818 3DMax MID Anatomical MeshC.R. Bard, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK192443 Dextile Anatomical MeshSofradim Production · 2019
- Descendant · cites it directly · 0 of its ownK142706 Modified ONFLEX MeshC.R. Bard, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K142711ONFLEX MeshC.R. Bard, Inc. · 2015 · cites it directly1descendant
- K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025 · 2 generations on0descendants
- K2008183DMax MID Anatomical MeshC.R. Bard, Inc. · 2020 · cites it directly0descendants
- K192443Dextile Anatomical MeshSofradim Production · 2019 · cites it directly0descendants
- K142706Modified ONFLEX MeshC.R. Bard, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091659 | Bard 3DMAX Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321… | C.R. Bard, Inc. | 2009 | — |
| +1 | K142711 | ONFLEX Mesh | C.R. Bard, Inc. | 2015 | — |
| +2 | K251955 | Onflex™ Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2025 | — |
| +1 | K200818 | 3DMax MID Anatomical Mesh | C.R. Bard, Inc. | 2020 | — |
| +1 | K192443 | Dextile Anatomical Mesh | Sofradim Production | 2019 | — |
| +1 | K142706 | Modified ONFLEX Mesh | C.R. Bard, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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? (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® Soft Mesh Named without a submission number | |
| * | — | Bard® 3DMAX™ Mesh Named without a submission number | |
| * | — | Mersilene Mesh Named without a submission number |
What descends from it? (5)
4 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?
- Of its descendants, K142711 (C.R. Bard, Inc., 2015) has gone furthest, with 1 descendant 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. 2009, 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 Bard® 3DMAx TM Light Mesh will be indicated for use in the reinforcement of soft tissue where weakness exists, such as the repair of hernia defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091659 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091659: Bard 3DMAX Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321, 011732.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091659
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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