De Novo · Granted
GrantediTind System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Tate, Ltd. · QKA Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Granted on Feb 25, 2020 as a new device type through De Novo after a 329-day review. 3 later devices descend from it.
- Decided
- Feb 25, 2020
- Review
- 329 days
- Class
- Class II
- Product code
- QKA
- Recalls
- None
3 later devices descend from it, 2 citing it directly.
- This deviceDEN190020 iTind SystemMedi-Tate, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK253525 Urocross Expander System (Model Numbers ES2018 and ES3025)Prodeon Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK261342 Urocross Expander System (UES-2018-C1)Prodeon Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK210138 iTind SystemMedi-Tate, Ltd. · 2021
Most influential descendants
Showing 3 of 3 · See all- K253525Urocross Expander System (Model Numbers ES2018 and ES3025)Prodeon Medical, Inc. · 2026 · cites it directly1descendant
- K261342Urocross Expander System (UES-2018-C1)Prodeon Medical, Inc. · 2026 · 2 generations on0descendants
- K210138iTind SystemMedi-Tate, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190020 | iTind System | Medi-Tate, Ltd. | 2020 | — |
| +1 | K253525 | Urocross Expander System (Model Numbers ES2018 and ES3025) | Prodeon Medical, Inc. | 2026 | — |
| +2 | K261342 | Urocross Expander System (UES-2018-C1) | Prodeon Medical, Inc. | 2026 | — |
| +1 | K210138 | iTind System | Medi-Tate, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA De Novo 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 QKA? 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 QKA device
- #1 K253525 Urocross Expander System (Model Numbers ES2018…score 14.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
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?
- Of its descendants, K253525 (Prodeon Medical, Inc., 2026) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QKA devicesQKA Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QKA
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QKA
Too few QKA 510(k)s in any year since 2007 to give a median.
Recalls per year · QKA
No recall names QKA since 2007.
Adverse event reports per year · QKA
5in 2025
MAUDE reports naming product code QKA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The iTind System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN190020 · printed Nov 3, 2026
Cite this page
510(k) Report. “DEN190020: iTind System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/DEN190020
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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