510(k) · Cleared
ClearedProceed Ventral Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ETHICON, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Dec 11, 2006 after a 192-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Dec 11, 2006
- Review
- 192 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 2 citing it directly.
- This deviceK061533 Proceed Ventral PatchETHICON, Inc. · 2006
- 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 · 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
- Descendant · 3 generations on · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K081777Ventrio Hernia PatchC.R. Bard, Inc. · 2008 · cites it directly14descendants
- K100229Ventrio Hernia PatchC.R. Bard, Inc. · 2010 · 2 generations on13descendants
- 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
- K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061533 | Proceed Ventral Patch | ETHICON, Inc. | 2006 | — |
| +1 | K081777 | Ventrio Hernia Patch | C.R. Bard, Inc. | 2008 | 4 |
| +2 | K100229 | Ventrio Hernia Patch | C.R. Bard, Inc. | 2010 | — |
| +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 | — |
| +3 | K133223 | Xenmatrix AB Surgical Graft | C.R. Bard, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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? (5)
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 |
|---|---|---|---|
| * | — | PROLENE* Soft Mesh Named without a submission number | |
| * | — | PROCEED* Mesh Named without a submission number | |
| * | — | BARD Ventralex & Small Ventralex Hernia Patch Named without a submission number | |
| * | — | VICRYL* Mesh Named without a submission number | |
| * | — | ETHIBOND* Polyester Suture Named without a submission number |
What descends from it? (16)
See all 162 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, K081777 (C.R. Bard, Inc., 2008) has gone furthest, with 14 descendants 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.
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?
PROCEED Ventral Patch is intended for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
PROCEED Ventral Patch is also indicated for the repair of tissue deficiencies caused by trocar use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061533 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061533: Proceed Ventral Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061533
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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