510(k) · Cleared
ClearedONFLEX Mesh
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 Mar 20, 2015 as substantially equivalent to K091659 (C.R. Bard, Inc., 2009) and 2 other predicates after a 179-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Mar 20, 2015
- Review
- 179 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K003323 (2001). 10 ancestors in all, the oldest K992189 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK003323 Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc. · 2001 · Recalled
- 3 generations backK061314 Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc. · 2006
- 2 generations backK081777 Ventrio Hernia PatchC.R. Bard, Inc. · 2008 · Recalled
- 1 generation backK100229 Ventrio Hernia PatchC.R. Bard, Inc. · 2010
- This deviceK142711 ONFLEX MeshC.R. Bard, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK251955 Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K003323 | Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205 | Davol, Inc. | 2001 | 3 |
| −3 | K061314 | Bard Extra Large Composix Kugel Hernia Patch | Davol Inc., Sub. C. R. Bard, Inc. | 2006 | — |
| −2 | K081777 | Ventrio Hernia Patch | C.R. Bard, Inc. | 2008 | 4 |
| −1 | K100229 | Ventrio Hernia Patch | C.R. Bard, Inc. | 2010 | — |
| 0 (this device) | K142711 | ONFLEX Mesh | C.R. Bard, Inc. | 2015 | — |
| +1 | K251955 | Onflex™ Mesh | Davol Inc., Subsidiary of C. R. Bard, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K091659 | Bard 3DMAX Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321, 011732Summary page 4…Class: - Class II Product Code: -FTL III. Predicate Devices Bard® 3DMax™ Light Mesh o K091659 (Davol, Inc.), FDA cleared on 08/08/2009 Bard® Ventrio™ Hernia Patch, o K081777 (Davol, Inc.), FDA clear… | 2009 |
| * | K081777 | Ventrio Hernia PatchSummary page 4…cate Devices Bard® 3DMax™ Light Mesh o K091659 (Davol, Inc.), FDA cleared on 08/08/2009 Bard® Ventrio™ Hernia Patch, o K081777 (Davol, Inc.), FDA cleared on 09/29/2008 o K100229 (Davol, Inc.), FDA cleared on 04/21/2010 No reference devices we… | 2008 |
| * | K100229 | Ventrio Hernia PatchSummary page 4…K091659 (Davol, Inc.), FDA cleared on 08/08/2009 Bard® Ventrio™ Hernia Patch, o K081777 (Davol, Inc.), FDA cleared on 09/29/2008 o K100229 (Davol, Inc.), FDA cleared on 04/21/2010 No reference devices were used in this submission. IV. Device Description The p… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251955 | Onflex™ Mesh | 2025 | 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K251955 (Davol Inc., Subsidiary of C. R. Bard, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K091659.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 ONFLEX™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142711: ONFLEX Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142711
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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