510(k) · Cleared
ClearedDesara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System
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 Nov 10, 2021 as substantially equivalent to K162201 (Caldera Medical, Inc., 2017) and 2 other predicates after a 138-day review. Its family tree reaches back 1 generation to 2017.
- Decided
- Nov 10, 2021
- Review
- 138 days
- Class
- Class II
- Product code
- OTN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K162201 (2017). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK162201 Desara TV, Desara Blue TVCaldera Medical, Inc. · 2017
- This deviceK211975 Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ…Caldera Medical, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K162201 | Desara TV, Desara Blue TV | Caldera Medical, Inc. | 2017 | — |
| 0 (this device) | K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7… | Caldera Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 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? (3)
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 |
|---|---|---|---|
| * | K162201 | Desara TV, Desara Blue TVSummary page 4…Incontinence Classification Panel: Gastroenterology/Urology Predicate Device: Desara® TV and Desara® Blue TV, 510(k) #K162201 (Primary) Caldera Medical Surgical Mesh Instruments, #K172614 (Primary)… | 2017 |
| * | K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator…Summary page 4…rology Predicate Device: Desara® TV and Desara® Blue TV, 510(k) #K162201 (Primary) Caldera Medical Surgical Mesh Instruments, #K172614 (Primary) Desara® One, 510(k) #K191416 (Reference) Description of Device: The Desara TV EZ and De… | 2018 |
| * | K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling…Summary page 4…510(k) #K162201 (Primary) Caldera Medical Surgical Mesh Instruments, #K172614 (Primary) Desara® One, 510(k) #K191416 (Reference) Description of Device: The Desara TV EZ and Desara Blue TV EZ Systems are comprised of sterile, single-use mid- ure… | 2020 |
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?
- None of the 3 ancestors has a recall.
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. 2021, 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?
Desara TV EZ and Desara Blue TV EZ are intended to be used in females to position a mesh for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
The 3.0mm or 2.7mm surgical mesh instruments are intended to be used in surgical procedures for the insertion and placement of Desara TV EZ and Desara Blue TV EZ surgical mesh indicated for treatment of Genuine Stress Urinary Incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211975: Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211975
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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