510(k) · Cleared
Recalled · 2010Ventrio Hernia Patch
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 Sep 29, 2008 as substantially equivalent to K061314 (Davol Inc., Sub. C. R. Bard, Inc., 2006) and 3 other predicates after a 98-day review. Its family tree reaches back 2 generations to 2001. 14 later devices descend from it. It has been recalled 4 times.
- Decided
- Sep 29, 2008
- Review
- 98 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 2 generations to K003323 (2001). 7 ancestors in all, the oldest K992189 (1999). 14 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK003323 Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205Davol, Inc. · 2001 · Recalled
- 1 generation backK061314 Bard Extra Large Composix Kugel Hernia PatchDavol Inc., Sub. C. R. Bard, Inc. · 2006
- This deviceK081777 Ventrio Hernia PatchC.R. Bard, Inc. · 2008
- Descendant · cites it directly · 13 of its ownK100229 Ventrio Hernia PatchC.R. Bard, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK113229 Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK101920 Ventrio ST Hernia PatchC.R. Bard, Inc. · 2011
- Descendant · 2 generations on · 2 of its ownK133223 Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK190185 Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc. · 2019
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K100229Ventrio Hernia PatchC.R. Bard, Inc. · 2010 · cites it directly13descendants
- K113229Ventrio Light Hernia Patch with TRM Antimicrobial CoatingC.R. Bard, Inc. · 2012 · cites it directly3descendants
- K101920Ventrio ST Hernia PatchC.R. Bard, Inc. · 2011 · cites it directly3descendants
- K133223Xenmatrix AB Surgical GraftC.R. Bard, Inc. · 2014 · 2 generations on2descendants
- K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003323 | Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205 | Davol, Inc. | 2001 | 3 |
| −1 | K061314 | Bard Extra Large Composix Kugel Hernia Patch | Davol Inc., Sub. C. R. Bard, Inc. | 2006 | — |
| 0 (this device) | K081777 | Ventrio Hernia Patch | C.R. Bard, Inc. | 2008 | — |
| +1 | K100229 | Ventrio Hernia Patch | C.R. Bard, Inc. | 2010 | — |
| +1 | K113229 | Ventrio Light Hernia Patch with TRM Antimicrobial Coating | C.R. Bard, Inc. | 2012 | — |
| +1 | K101920 | Ventrio ST Hernia Patch | C.R. Bard, Inc. | 2011 | — |
| +2 | K133223 | Xenmatrix AB Surgical Graft | C.R. Bard, Inc. | 2014 | — |
| +2 | K190185 | Phasix ST Mesh with Open Positioning System | C.R. Bard, Inc. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K061314 | Bard Extra Large Composix Kugel Hernia PatchSummary page 1…e. *The Ventrio Hernia Patch is substantially equivalent to the modified Bard Composix Kugel Hernia Patch containing the re-designed recoil ring covered under 510(k) K0613 14, cleared on June 2, 2006 PREMARKET NOTIFICATION FOR THE VENTRIo HERNIA PATCH… | 2006 |
| * | K061533 | Proceed Ventral PatchSummary page 1…rnia Patch* (Davol Inc.) (KO613 14); Ethicon PROCEED Ventral Patch (K061533); W.L. Gore INFINIT Mesh (K08 1069) and DualMeshg… | 2006 |
| * | K081069 | Gore Infinit MeshSummary page 1…); Ethicon PROCEED Ventral Patch (K061533); W.L. Gore INFINIT Mesh (K08 1069) and DualMeshg EMERGE PLUS Biomnaterial (K022782). D. Device Descriptio… | 2008 |
| * | K022782 | Dualmesh Emerge & Emerge Plus BiomaterialSummary page 1…ore INFINIT Mesh (K08 1069) and DualMeshg EMERGE PLUS Biomnaterial (K022782). D. Device Description The proposed Ventrio Hernia Patch isa self-expanding, sterile prosthesis, conta… | 2002 |
What descends from it? (14)
See all 147 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2010 | Not classified | Z-0422-2011 | Packaging process control | Mislabeled: Hernia Patch may be a different size than on the product label |
| Oct 15, 2010 | Not classified | Z-0423-2011 | Packaging process control | Mislabeled: Hernia Patch may be a different size than on the product label |
| Oct 15, 2010 | Not classified | Z-0424-2011 | Packaging process control | Mislabeled: Hernia Patch may be a different size than on the product label |
| Apr 8, 2010 | Not classified | Z-1536-2010 | Labeling mix-ups | Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0") |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K100229 (C.R. Bard, Inc., 2010) has gone furthest, with 13 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. 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?
The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081777: Ventrio Hernia Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081777
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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