510(k) · Cleared
ClearedOnflex™ Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davol Inc., Subsidiary of C. R. Bard, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jul 24, 2025 as substantially equivalent to K142711 (C.R. Bard, Inc., 2015) after a 29-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jul 24, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003323 (2001). 11 ancestors in all, the oldest K992189 (1999). No later device cites it as a predicate yet.
- Root · 5 generations backK003323 Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc. · 2001 · Recalled
- 4 generations backK061314 Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc. · 2006
- 3 generations backK081777 Ventrio Hernia PatchC.R. Bard, Inc. · 2008 · Recalled
- 2 generations backK100229 Ventrio Hernia PatchC.R. Bard, Inc. · 2010
- 1 generation backK142711 ONFLEX MeshC.R. Bard, Inc. · 2015
- This deviceK251955 Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003323 | Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205 | Davol, Inc. | 2001 | 3 |
| −4 | K061314 | Bard Extra Large Composix Kugel Hernia Patch | Davol Inc., Sub. C. R. Bard, Inc. | 2006 | — |
| −3 | K081777 | Ventrio Hernia Patch | C.R. Bard, Inc. | 2008 | 4 |
| −2 | K100229 | Ventrio Hernia Patch | C.R. Bard, Inc. | 2010 | — |
| −1 | K142711 | ONFLEX Mesh | C.R. Bard, Inc. | 2015 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K142711 | ONFLEX MeshSummary page 5…gical, Polymeric Regulatory Class: II Regulation Number: 21 CFR 878.3300 Product Code: FTL Predicate Device: Device Trade Name: OnFlex™ Mesh (K142711), cleared on March 20, 2015 Common Name: Surgical mesh Classification Name: Mesh, Surgical, Polymeric Regulatory C… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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/K251955 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251955: Onflex™ Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251955
Report an extraction error
Are you the manufacturer?
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