510(k) · Cleared
ClearediTind 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
Cleared on Jun 25, 2021 as substantially equivalent to DEN190020 (Medi-Tate, Ltd., 2020) after a 157-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Jun 25, 2021
- Review
- 157 days
- Class
- Class II
- Product code
- QKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190020 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backDEN190020 iTind SystemMedi-Tate, Ltd. · 2020
- This deviceK210138 iTind SystemMedi-Tate, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190020 | iTind System | Medi-Tate, Ltd. | 2020 | — |
| 0 (this device) | K210138 | iTind System | Medi-Tate, Ltd. | 2021 | — |
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 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
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 |
|---|---|---|---|
| * | DEN190020 | iTind SystemSummary page 4…ystem for Symptoms of Benign Prostatic Hyperplasia Regulation Number: 21 CFR 876.5510 Regulatory Class: II Product Code: QKA Predicate Device: DEN190020 – Medi-Tate’s iTind Device Description The iTind System is a prescription temporary implantable transprostatic tissue re… | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN190020.
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. 2021, 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/K210138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210138: iTind System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210138
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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