510(k) · Cleared
ClearedDesara Mesh Model: Cal-DS01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caldera Medical, Inc. · OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Cleared on May 20, 2010 as substantially equivalent to K072456 (Caldera Medical, Inc., 2008) after a 24-day review. Its family tree reaches back 4 generations to 1998. 5 later devices descend from it.
- Decided
- May 20, 2010
- Review
- 24 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K974098 (1998). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK974098 Pubouurethral SlingETHICON, Inc. · 1998
- 3 generations backK020652 Herniamesh T-SlingHerniamesh · 2002
- 2 generations backK050516 T-SlingHerniamesh S.R.L. · 2006
- 1 generation backK072456 Desara Mesh Sling, Model Cal-DS01Caldera Medical, Inc. · 2008
- This deviceK101169 Desara Mesh Model: Cal-DS01Caldera Medical, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK112609 Desara MeshCaldera Medical, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK132069 Desara Mesh, Desara BlueCaldera Medical, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK140843 Desara Blue OV, Desara Blue SSCaldera Medical · 2014
- Descendant · 2 generations on · 0 of its ownK121928 Desara SLCaldera Medical, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK103418 Desara MiniCaldera Medical, Inc. · 2011
Most influential descendants
Showing 5 of 5 · See all- K112609Desara MeshCaldera Medical, Inc. · 2011 · cites it directly3descendants
- K132069Desara Mesh, Desara BlueCaldera Medical, Inc. · 2013 · 2 generations on1descendant
- K140843Desara Blue OV, Desara Blue SSCaldera Medical · 2014 · 3 generations on0descendants
- K121928Desara SLCaldera Medical, Inc. · 2013 · 2 generations on0descendants
- K103418Desara MiniCaldera Medical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974098 | Pubouurethral Sling | ETHICON, Inc. | 1998 | — |
| −3 | K020652 | Herniamesh T-Sling | Herniamesh | 2002 | — |
| −2 | K050516 | T-Sling | Herniamesh S.R.L. | 2006 | — |
| −1 | K072456 | Desara Mesh Sling, Model Cal-DS01 | Caldera Medical, Inc. | 2008 | — |
| 0 (this device) | K101169 | Desara Mesh Model: Cal-DS01 | Caldera Medical, Inc. | 2010 | — |
| +1 | K112609 | Desara Mesh | Caldera Medical, Inc. | 2011 | — |
| +2 | K132069 | Desara Mesh, Desara Blue | Caldera Medical, Inc. | 2013 | — |
| +3 | K140843 | Desara Blue OV, Desara Blue SS | Caldera Medical | 2014 | — |
| +2 | K121928 | Desara SL | Caldera Medical, Inc. | 2013 | — |
| +1 | K103418 | Desara Mini | Caldera Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 OTN? 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 OTN device
- #1 K231549 Advantage Ultra System, Advantage Fit Ultra…score 6.8 · 5 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 |
|---|---|---|---|
| * | K072456 | Desara Mesh Sling, Model Cal-DS01Summary page 1…ss: Class IlI, Product Code OTN, 21 CFR 878.3300, Gynecologic, For Stress Urinary Incontinence, Female, Obstetrics/Gynecology Panel Predicate Device: Desara Mesh Sling, K072456, Caldera Medical, Inc. Description of Device: The Desara Mesh Sling is a sterile, single-use pubourethral sling used to provide… | 2008 |
What descends from it? (5)
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)
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 12 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K112609 (Caldera Medical, Inc., 2011) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K072456.
How does its category compare?
All OTN devicesOTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OTN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OTN
89in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OTN
458in 2025
MAUDE reports naming product code OTN, 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 | 2 | — | 0 | 0 |
| 2008 | 3 | 100 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 5 | 25 | 0 | 1 |
| 2011 | 4 | 56 | 0 | 25 |
| 2012 | 1 | — | 0 | 874 |
| 2013 | 5 | 86 | 0 | 19,084 |
| 2014 | 1 | — | 1 | 2,063 |
| 2015 | 0 | — | 0 | 3,904 |
| 2016 | 0 | — | 0 | 1,902 |
| 2017 | 1 | — | 0 | 676 |
| 2018 | 0 | — | 0 | 737 |
| 2019 | 1 | — | 0 | 2,457 |
| 2020 | 1 | — | 0 | 1,003 |
| 2021 | 3 | 89 | 0 | 2,606 |
| 2022 | 2 | — | 0 | 809 |
| 2023 | 1 | — | 0 | 1,076 |
| 2024 | 0 | — | 0 | 822 |
| 2025 | 0 | — | 0 | 458 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Desara® Mesh is intended to be used in females to position a mesh for the treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
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/K101169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101169: Desara Mesh Model: Cal-DS01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101169
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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