510(k) · Cleared
ClearedVertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caldera Medical · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on Feb 21, 2013 as substantially equivalent to K120327 (Caldera Medical, Inc., 2012) after a 113-day review. Its family tree reaches back 12 generations to 1993. 1 later device descends from it.
- Decided
- Feb 21, 2013
- Review
- 113 days
- Class
- Class II
- Product code
- OTO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K931386 (1993). 28 ancestors in all, the oldest K922916 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 8 generations between
- 3 generations backK083722 AscendCaldera Medical, Inc. · 2009
- 2 generations backK101462 Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc. · 2010
- 1 generation backK120327 VertessaCaldera Medical, Inc. · 2012
- This deviceK123337 Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical · 2013
- Descendant · cites it directly · 0 of its ownK150016 Vertessa LiteCaldera Medical, Inc. · 2015
Show all 12 generations
- Root · 12 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 11 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 10 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 9 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 8 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 7 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 6 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 5 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 4 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 3 generations backK083722 AscendCaldera Medical, Inc. · 2009
- 2 generations backK101462 Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc. · 2010
- 1 generation backK120327 VertessaCaldera Medical, Inc. · 2012
- This deviceK123337 Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical · 2013
Most influential descendants
Showing 1 of 1 · See all- K150016Vertessa LiteCaldera Medical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −11 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −10 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −9 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −8 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −7 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −6 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −5 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −4 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −3 | K083722 | Ascend | Caldera Medical, Inc. | 2009 | — |
| −2 | K101462 | Ascend Blue AC Mesh; Ascend Blue PC Mesh | Caldera Medical, Inc. | 2010 | — |
| −1 | K120327 | Vertessa | Caldera Medical, Inc. | 2012 | — |
| 0 (this device) | K123337 | Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM | Caldera Medical | 2013 | — |
| +1 | K150016 | Vertessa Lite | Caldera Medical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 OTO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K120327 | VertessaSummary page 1…ication: Class II, Product Code: OTO, Surgical Mesh, Gynecologic, 21 CFR 878.3300, General and Plastic Surgery Predicate: Vertessa T M (K120327), Caldera Medical, Inc. Description of. Device: VertessaTm Lite devices are designed to be used in women suffering from… | 2012 |
| † | K101462 | Ascend Blue AC Mesh; Ascend Blue PC Mesh | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150016 | Vertessa Lite | 2015 | 0 |
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 20 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K150016 (Caldera Medical, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K120327.
How does its category compare?
All OTO devicesOTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OTO
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · OTO
95in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTO
No recall names OTO since 2007.
Adverse event reports per year · OTO
79in 2025
MAUDE reports naming product code OTO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 7 | 101 | 0 | 160 |
| 2013 | 4 | 95 | 0 | 2,272 |
| 2014 | 1 | — | 0 | 267 |
| 2015 | 2 | — | 0 | 448 |
| 2016 | 0 | — | 0 | 156 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 0 | — | 0 | 145 |
| 2019 | 0 | — | 0 | 347 |
| 2020 | 0 | — | 0 | 153 |
| 2021 | 0 | — | 0 | 292 |
| 2022 | 0 | — | 0 | 112 |
| 2023 | 0 | — | 0 | 101 |
| 2024 | 0 | — | 0 | 113 |
| 2025 | 0 | — | 0 | 79 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VertessaTM Lite may be used for the repair of uterine or vaginal vault prolapse that
require support material, It may be used in open or laparoscopic abdominal procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123337 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123337: Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123337
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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