510(k) · Cleared
Recalled · Class II · 2012Ventralight ST Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davol Inc., Sub. C. R. Bard, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Jul 15, 2010 as substantially equivalent to K040868 (Genzyme Corp., 2004) and 2 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1997. 10 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 15, 2010
- Review
- 14 days
- Class
- Class II
- Product code
- FTL
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K971745 (1997). 8 ancestors in all, the oldest K810428 (1981). 10 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK971745 Bard Composite ProsthesisDavol Inc., Sub. C. R. Bard, Inc. · 1997
- 4 generations backK994328 Sepramesh Biosurgical Composite, Model SMBC-XXXGenzyme Corp. · 2000
- 3 generations backK040868 Sepramesh IP Bioresorbable Barrier - Permanent MeshGenzyme Corp. · 2004
- 2 generations backK053066 Sepramesh IP Bioresorbable Coating/Permanent MeshGenzyme Corporation · 2005
- 1 generation backK063739 Sepramesh, Model 5959-1214Genzyme Corporation · 2007
- This deviceK101851 Ventralight ST MeshDavol Inc., Sub. C. R. Bard, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK110820 Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK143380 Phasix ST MeshC.R. Bard, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK122436 Composix L/P Mesh with Echo PS Positioning System Ventralight ST…C.R. Bard, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 3 of its ownK130968 Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK143743 ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K110820Ventralight (TM) ST Mesh with Echo PS (TM) Positioning SystemC.R. Bard, Inc. · 2011 · cites it directly5descendants
- K143380Phasix ST MeshC.R. Bard, Inc. · 2015 · cites it directly4descendants
- K122436Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with Echo PS…C.R. Bard, Inc. · 2012 · 2 generations on4descendants
- K130968Ventralight ST Mesh with Echo PS Positioning SystemC.R. Bard, Inc. · 2013 · 3 generations on3descendants
- K143743ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESHC.R. Bard, Inc. · 2015 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971745 | Bard Composite Prosthesis | Davol Inc., Sub. C. R. Bard, Inc. | 1997 | — |
| −4 | K994328 | Sepramesh Biosurgical Composite, Model SMBC-XXX | Genzyme Corp. | 2000 | — |
| −3 | K040868 | Sepramesh IP Bioresorbable Barrier - Permanent Mesh | Genzyme Corp. | 2004 | — |
| −2 | K053066 | Sepramesh IP Bioresorbable Coating/Permanent Mesh | Genzyme Corporation | 2005 | — |
| −1 | K063739 | Sepramesh, Model 5959-1214 | Genzyme Corporation | 2007 | — |
| 0 (this device) | K101851 | Ventralight ST Mesh | Davol Inc., Sub. C. R. Bard, Inc. | 2010 | — |
| +1 | K110820 | Ventralight (TM) ST Mesh with Echo PS (TM) Positioning System | C.R. Bard, Inc. | 2011 | — |
| +1 | K143380 | Phasix ST Mesh | C.R. Bard, Inc. | 2015 | — |
| +2 | K122436 | Composix L/P Mesh with Echo PS Positioning System Ventralight ST Mesh with… | C.R. Bard, Inc. | 2012 | 15 |
| +3 | K130968 | Ventralight ST Mesh with Echo PS Positioning System | C.R. Bard, Inc. | 2013 | 4 |
| +2 | K143743 | ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH | C.R. Bard, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K040868 | Sepramesh IP Bioresorbable Barrier - Permanent MeshSummary page 1…Surgical Mesh Class: Class II, 21 CFR 878.3300, Product Code FTL Predicate Device(s): Sepramesh IP Bioresorbable Coating/Permanent Mesh (K040868, K053066, K063739) Device Description: The Ventralight ST Mesh is a low profile, sterile, single use device indicated for us… | 2004 |
| * | K053066 | Sepramesh IP Bioresorbable Coating/Permanent MeshSummary page 1…rgical Mesh Class: Class II, 21 CFR 878.3300, Product Code FTL Predicate Device(s): Sepramesh IP Bioresorbable Coating/Permanent Mesh (K040868, K053066, K063739) Device Description: The Ventralight ST Mesh is a low profile, sterile, single use device indicated for use in the… | 2005 |
| * | K063739 | Sepramesh, Model 5959-1214Summary page 1…Class: Class II, 21 CFR 878.3300, Product Code FTL Predicate Device(s): Sepramesh IP Bioresorbable Coating/Permanent Mesh (K040868, K053066, K063739) Device Description: The Ventralight ST Mesh is a low profile, sterile, single use device indicated for use in the reconstructi… | 2007 |
What descends from it? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2012 | Class II | Z-2413-2012 | Mixed-up of materials/components | Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh |
| Sep 4, 2012 | Class II | Z-2412-2012 | Mixed-up of materials/components | Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh product |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K110820 (C.R. Bard, Inc., 2011) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K040868.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Ventralight ST Mesh is intended for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K101851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101851: Ventralight ST Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101851
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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