510(k) · Cleared
ClearedVertessa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caldera Medical, Inc. · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
Cleared on May 10, 2012 as substantially equivalent to K101462 (Caldera Medical, Inc., 2010) and 1 other predicate after a 98-day review. Its family tree reaches back 11 generations to 1993. 5 later devices descend from it.
- Decided
- May 10, 2012
- Review
- 98 days
- Class
- Class II
- Product code
- OTO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K931386 (1993). 27 ancestors in all, the oldest K922916 (1992). 5 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 7 generations between
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK083722 AscendCaldera Medical, Inc. · 2009
- 1 generation backK101462 Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc. · 2010
- This deviceK120327 VertessaCaldera Medical, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK123337 Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical · 2013
- Descendant · cites it directly · 1 of its ownK122440 Restorelle LColoplast Corp. · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK150016 Vertessa LiteCaldera Medical, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK132061 Restorelle M, Restorelle XLColoplast Corp. · 2013
- Descendant · cites it directly · 0 of its ownK122968 Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp. · 2012
Show all 11 generations
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 9 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 8 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 7 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 6 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 5 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 4 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK083722 AscendCaldera Medical, Inc. · 2009
- 1 generation backK101462 Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc. · 2010
- This deviceK120327 VertessaCaldera Medical, Inc. · 2012
Most influential descendants
Showing 5 of 5 · See all- K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical · 2013 · cites it directly1descendant
- K122440Restorelle LColoplast Corp. · 2012 · cites it directly1descendant
- K150016Vertessa LiteCaldera Medical, Inc. · 2015 · 2 generations on0descendants
- K132061Restorelle M, Restorelle XLColoplast Corp. · 2013 · 2 generations on0descendants
- K122968Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015Coloplast Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −10 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −9 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −8 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −7 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −6 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −5 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −4 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −3 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −2 | K083722 | Ascend | Caldera Medical, Inc. | 2009 | — |
| −1 | K101462 | Ascend Blue AC Mesh; Ascend Blue PC Mesh | Caldera Medical, Inc. | 2010 | — |
| 0 (this device) | K120327 | Vertessa | Caldera Medical, Inc. | 2012 | — |
| +1 | K123337 | Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM | Caldera Medical | 2013 | — |
| +1 | K122440 | Restorelle L | Coloplast Corp. | 2012 | 1 |
| +2 | K150016 | Vertessa Lite | Caldera Medical, Inc. | 2015 | — |
| +2 | K132061 | Restorelle M, Restorelle XL | Coloplast Corp. | 2013 | — |
| +1 | K122968 | Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015 | Coloplast Corp. | 2012 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K101462 | Ascend Blue AC Mesh; Ascend Blue PC MeshSummary page 1…s intended use, technological characteristics and performance. vertessaTM iscomprised of the same mesh as the predicate device, Ascend® Blue, FDA 510(k) #K1 01462, also a product of Caldera Medical. Inaccordance with the FDA s Guidance for the Preparation of a Premarket Notification… | 2010 |
| * | K053424 | PopmeshSummary page 1…CFR 878.3300, General And Plastic Surgery Predicate Device: Ascend® Blue (K1I01462), Caldera Medical Inc. POPMeShN (K053424), Caldera Medical, Inc. Description of Device: VertessaT is designed to be used in the inpatient or outpatient surgery set… | 2006 |
What descends from it? (5)
3 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 19 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K123337 (Caldera Medical, 2013) has gone furthest, with 1 descendant of its own.
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. 2012, 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?
Vertessa TM may be used for the repair of uterine or vaginal vault prolapse that requires support material. It may be used in open or lapamoscopic abdominal procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120327 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120327: Vertessa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120327
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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