510(k) · Cleared
ClearedAscend Blue AC Mesh; Ascend Blue PC Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caldera Medical, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Aug 16, 2010 as substantially equivalent to K083722 (Caldera Medical, Inc., 2009) after an 82-day review. Its family tree reaches back 10 generations to 1993. 6 later devices descend from it.
- Decided
- Aug 16, 2010
- Review
- 82 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K931386 (1993). 24 ancestors in all, the oldest K922916 (1992). 6 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 6 generations between
- 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 1 generation backK083722 AscendCaldera Medical, Inc. · 2009
- This deviceK101462 Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc. · 2010
- Descendant · cites it directly · 5 of its ownK120327 VertessaCaldera Medical, Inc. · 2012
- Descendant · 2 generations on · 1 of its ownK123337 Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical · 2013
- Descendant · 2 generations on · 1 of its ownK122440 Restorelle LColoplast Corp. · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK150016 Vertessa LiteCaldera Medical, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK132061 Restorelle M, Restorelle XLColoplast Corp. · 2013
Show all 10 generations
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 8 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 7 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 6 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 5 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 4 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 1 generation backK083722 AscendCaldera Medical, Inc. · 2009
- This deviceK101462 Ascend Blue AC Mesh; Ascend Blue PC MeshCaldera Medical, Inc. · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K120327VertessaCaldera Medical, Inc. · 2012 · cites it directly5descendants
- K123337Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CMCaldera Medical · 2013 · 2 generations on1descendant
- K122440Restorelle LColoplast Corp. · 2012 · 2 generations on1descendant
- K150016Vertessa LiteCaldera Medical, Inc. · 2015 · 3 generations on0descendants
- K132061Restorelle M, Restorelle XLColoplast Corp. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −9 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −8 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −7 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −6 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −5 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −4 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −3 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −2 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −1 | K083722 | Ascend | Caldera Medical, Inc. | 2009 | — |
| 0 (this device) | K101462 | Ascend Blue AC Mesh; Ascend Blue PC Mesh | Caldera Medical, Inc. | 2010 | — |
| +1 | K120327 | Vertessa | Caldera Medical, Inc. | 2012 | — |
| +2 | K123337 | Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM | Caldera Medical | 2013 | — |
| +2 | K122440 | Restorelle L | Coloplast Corp. | 2012 | 1 |
| +3 | K150016 | Vertessa Lite | Caldera Medical, Inc. | 2015 | — |
| +3 | K132061 | Restorelle M, Restorelle XL | Coloplast Corp. | 2013 | — |
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 |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K083722 | AscendSummary page 1…Classification Name ~ Mesh, Surgical, Polymeric Regulation No. 878.3300 Product Code FTL ' 510(k) Number K101462 Predicate Device: Ascend® Mesh (Caldera Medical, Inc.) K083722 Description of Device: : Ascend®Blue Mesh is designed to be used in the inpatient or outpatient surgery setting for use in women… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120327 | Vertessa | 2012 | 5 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 24 ancestors have a recall of any class.
- Of its descendants, K120327 (Caldera Medical, Inc., 2012) has gone furthest, with 5 descendants of its own.
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?
Ascend® Blue AC and Ascend® Blue 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/K101462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101462: Ascend Blue AC Mesh; Ascend Blue PC Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101462
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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