510(k) · Cleared
ClearedDesara Mini
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caldera Medical, Inc. · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
Cleared on Nov 30, 2011 as substantially equivalent to K101169 (Caldera Medical, Inc., 2010) and 1 other predicate after a 373-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Nov 30, 2011
- Review
- 373 days
- Class
- Class II
- Product code
- PAH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K011251 (2001). 16 ancestors in all, the oldest K974098 (1998). No later device cites it as a predicate yet.
- Root · 8 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 7 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
- 6 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 5 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
- 4 generations backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
- 3 generations backK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
- 2 generations backK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
- 1 generation backK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
- This deviceK103418 Desara MiniCaldera Medical, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011251 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −7 | K013355 | Sparc Sling System | American Medical Systems, Inc. | 2001 | — |
| −6 | K020663 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −5 | K021263 | Modification to Sparc Sling System | American Medical Systems, Inc. | 2002 | — |
| −4 | K023516 | Monarc Sling System | American Medical Systems, Inc. | 2002 | 1 |
| −3 | K070065 | Ams Single Incision Sling System (Sis-0) | American Medical Systems, Inc. | 2007 | — |
| −2 | K071902 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2007 | — |
| −1 | K073703 | Ams Miniarc Sling System | American Medical Systems, Inc. | 2008 | — |
| 0 (this device) | K103418 | Desara Mini | Caldera Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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 PAH? 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 PAH device
- #1 K242473 Altis Single Incision Sling System (519650)…score 10.9 · 10 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K101169 | Desara Mesh Model: Cal-DS01Summary page 1…5 x 102 Surgical Mesh (878.3300) Desara Mini ) Surgical Mesh . Class Il, Product Code FTL, 21 CFR 878.3300, Surgical Mesh, Plastic and General Surgery Desara mesh, #K101169 MiniArc, #K073703 sterile, single-use pubourethral sling. The device is comprised of monofilament polypropylene yarn, which is… | 2010 |
| * | K073703 | Ams Miniarc Sling SystemSummary page 1…esh (878.3300) Desara Mini ) Surgical Mesh . Class Il, Product Code FTL, 21 CFR 878.3300, Surgical Mesh, Plastic and General Surgery Desara mesh, #K101169 MiniArc, #K073703 sterile, single-use pubourethral sling. The device is comprised of monofilament polypropylene yarn, which is knitted into a mes… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K101169.
How does its category compare?
All PAH devicesPAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · PAH
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PAH
128in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PAH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PAH
242in 2025
MAUDE reports naming product code PAH, 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 | 61 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 7 |
| 2012 | 4 | 128 | 0 | 129 |
| 2013 | 0 | — | 0 | 2,386 |
| 2014 | 0 | — | 0 | 338 |
| 2015 | 0 | — | 1 | 275 |
| 2016 | 0 | — | 0 | 697 |
| 2017 | 0 | — | 0 | 127 |
| 2018 | 0 | — | 0 | 174 |
| 2019 | 0 | — | 0 | 298 |
| 2020 | 1 | — | 0 | 171 |
| 2021 | 0 | — | 0 | 318 |
| 2022 | 0 | — | 0 | 159 |
| 2023 | 1 | — | 0 | 154 |
| 2024 | 1 | — | 0 | 287 |
| 2025 | 0 | — | 0 | 242 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Desara Mini is intended to be used in females to position a suburethral mesh sling for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence resulting from urethral hypermobility. The mesh is placed transvaginally using a reusable introducer (sold separately)
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/K103418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103418: Desara Mini.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103418
Report an extraction error
Are you the manufacturer?
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