510(k) · Cleared
ClearedAscend
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caldera Medical, Inc. · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Cleared on Mar 31, 2009 as substantially equivalent to K040537 (American Medical Systems, Inc., 2004) and 1 other predicate after a 106-day review. Its family tree reaches back 9 generations to 1993. 7 later devices descend from it.
- Decided
- Mar 31, 2009
- Review
- 106 days
- Class
- Class III
- Product code
- OTP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K931386 (1993). 23 ancestors in all, the oldest K922916 (1992). 7 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 5 generations between
- 3 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 2 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 1 generation backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- This deviceK083722 AscendCaldera Medical, Inc. · 2009
- Descendant · cites it directly · 6 of its ownK101462 Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc. · 2010
- Descendant · 2 generations on · 5 of its ownK120327 VertessaCaldera Medical, Inc. · 2012
- Descendant · 3 generations on · 1 of its ownK123337 Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical · 2013
- Descendant · 3 generations on · 1 of its ownK122440 Restorelle LColoplast Corp. · 2012 · Recalled
- Descendant · 4 generations on · 0 of its ownK150016 Vertessa LiteCaldera Medical, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 8 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 7 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 6 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 5 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 4 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 3 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 2 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 1 generation backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- This deviceK083722 AscendCaldera Medical, Inc. · 2009
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K101462Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc. · 2010 · cites it directly6descendants
- K120327VertessaCaldera Medical, Inc. · 2012 · 2 generations on5descendants
- K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical · 2013 · 3 generations on1descendant
- K122440Restorelle LColoplast Corp. · 2012 · 3 generations on1descendant
- K150016Vertessa LiteCaldera Medical, Inc. · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −8 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −7 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −6 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −5 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −4 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −3 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −2 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −1 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K083722 | Ascend | Caldera Medical, Inc. | 2009 | — |
| +1 | K101462 | Ascend Blue AC Mesh; Ascend Blue PC Mesh | Caldera Medical, Inc. | 2010 | — |
| +2 | K120327 | Vertessa | Caldera Medical, Inc. | 2012 | — |
| +3 | K123337 | Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM | Caldera Medical | 2013 | — |
| +3 | K122440 | Restorelle L | Coloplast Corp. | 2012 | 1 |
| +4 | 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 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 3 | 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 OTP? 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 |
|---|---|---|---|
| * | K040537 | Ams Apogee Vault Suspension SystemSummary page 1…Affairs Manager P 818.879.6555 x 105 F 818.879.6556 E [email protected] Surgical Mesh (878.3300) Ascend Surgical Mesh AMS Apogee Vault Suspension System K040537 AMS Perigee System K040623 The Ascend Pelvic Floor Repair System consists of macroporous, monofilament, polypropylene mesh impla… | 2004 |
| * | K040623 | Ams Perigee SystemSummary page 1…6555 x 105 F 818.879.6556 E [email protected] Surgical Mesh (878.3300) Ascend Surgical Mesh AMS Apogee Vault Suspension System K040537 AMS Perigee System K040623 The Ascend Pelvic Floor Repair System consists of macroporous, monofilament, polypropylene mesh implants and a set of reusable i… | 2004 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101462 | Ascend Blue AC Mesh; Ascend Blue PC Mesh | 2010 | 6 |
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 16 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 3 of the 23 ancestors have a recall of any class.
- Of its descendants, K101462 (Caldera Medical, Inc., 2010) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K040537.
How does its category compare?
All OTP devicesOTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · OTP
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OTP
71in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTP
No recall names OTP since 2007.
Adverse event reports per year · OTP
26in 2025
MAUDE reports naming product code OTP, 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 | 4 | 90 | 0 | 1 |
| 2008 | 8 | 103 | 0 | 0 |
| 2009 | 6 | 21 | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 5 | 71 | 0 | 32 |
| 2012 | 2 | — | 0 | 494 |
| 2013 | 0 | — | 0 | 7,150 |
| 2014 | 0 | — | 0 | 778 |
| 2015 | 0 | — | 0 | 684 |
| 2016 | 0 | — | 0 | 415 |
| 2017 | 0 | — | 0 | 273 |
| 2018 | 0 | — | 0 | 392 |
| 2019 | 0 | — | 0 | 368 |
| 2020 | 0 | — | 0 | 175 |
| 2021 | 0 | — | 0 | 647 |
| 2022 | 0 | — | 0 | 114 |
| 2023 | 0 | — | 0 | 59 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Ascend AC and Ascend PC are indicated for repair of pelvic organ prolapse, including anterior, posterior, vaginal vault and uterine prolapse.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K083722 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083722: Ascend.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083722
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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