510(k) · Cleared
ClearedVentralight (TM) ST Mesh with Echo PS (TM) Positioning System
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 Apr 1, 2011 as substantially equivalent to K101851 (Davol Inc., Sub. C. R. Bard, Inc., 2010) and 1 other predicate after a 9-day review. Its family tree reaches back 6 generations to 1997. 5 later devices descend from it.
- Decided
- Apr 1, 2011
- Review
- 9 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K971745 (1997). 33 ancestors in all, the oldest K810428 (1981). 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
- 5 generations backK994328 Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp. · 2000
- 4 generations backK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
- 3 generations backK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
- 2 generations backK063739 Sepramesh, Model 5959-1214Genzyme Corporation · 2007
- 1 generation backK101851 Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 2010 · Recalled
- This deviceK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK170294 VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”)…C. R. Bard · 2017
- Descendant · 3 generations on · 0 of its ownK182008 Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · cites it directly4descendants
- K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · 2 generations on3descendants
- K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015 · cites it directly2descendants
- K170294VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST…C. R. Bard · 2017 · 2 generations on1descendant
- K182008Phasix ST Mesh with Echo 2 Positioning SystemC.R. Bard, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K971745 | Bard Composite Prosthesis | Davol Inc., Sub. C. R. Bard, Inc. | 1997 | — |
| −5 | K994328 | Sepramesh Biosurgical Composite, Model SMBC-XXX | Genzyme Corp. | 2000 | — |
| −4 | K040868 | Sepramesh IP Bioresorbable Barrier - Permanent Mesh | Genzyme Corp. | 2004 | — |
| −3 | K053066 | Sepramesh IP Bioresorbable Coating/Permanent Mesh | Genzyme Corporation | 2005 | — |
| −2 | K063739 | Sepramesh, Model 5959-1214 | Genzyme Corporation | 2007 | — |
| −1 | K101851 | Ventralight ST Mesh | Davol Inc., Sub. C. R. Bard, Inc. | 2010 | 2 |
| 0 (this device) | K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System | C.R. Bard, Inc. | 2011 | — |
| +1 | K122436 | Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with… | C.R. Bard, Inc. | 2012 | 15 |
| +2 | K130968 | Ventralight ST Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2013 | 4 |
| +1 | K143743 | ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH | C.R. Bard, Inc. | 2015 | — |
| +2 | K170294 | VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle… | C. R. Bard | 2017 | — |
| +3 | K182008 | Phasix ST Mesh with Echo 2 Positioning System | C.R. Bard, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K101851 | Ventralight ST MeshSummary page 3…l to the inflation assembly cleared under K102766. The proposed product will combine into one the currently marketed Ventralightm ST Mesh cleared under K1 01851, preassembled with the currently marketed Echo P5TM Positioning System cleared as part of K102766. The proposed product wil… | 2010 |
| * | K102766 | Composix L/P Mesh with Echo PS Positioning SystemSummary page 2…ST Mesh described above Will be packaged preassembled with the Echo P5Th Positioning System, a removable mesh deployment balloon, previously cleared under K 102766. The positioning system is an RE welded nylon balloon that is pre-attached to the mesh via the use of polycarbonate connec… | 2010 |
What descends from it? (5)
2 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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 33 ancestors have a recall of any class.
- Of its descendants, K122436 (C.R. Bard, Inc., 2012) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K101851.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Ventralight ST Mesh is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias. The Echo PS Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic hernia repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110820: Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110820
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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