510(k) · Cleared
ClearedUrocross Expander System (Model Numbers ES2018 and ES3025)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prodeon Medical, Inc. · QKA Temporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Cleared on Mar 12, 2026 as substantially equivalent to DEN190020 (Medi-Tate, Ltd., 2020) after a 119-day review. Its family tree reaches back 1 generation to 2020. 1 later device descends from it.
- Decided
- Mar 12, 2026
- Review
- 119 days
- Class
- Class II
- Product code
- QKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190020 (2020). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K261342Urocross Expander System (UES-2018-C1)Prodeon Medical, Inc. · 2026 · cites it directly0descendants
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) | K253525 | Urocross Expander System (Model Numbers ES2018 and ES3025) | Prodeon Medical, Inc. | 2026 | — |
| +1 | K261342 | Urocross Expander System (UES-2018-C1) | Prodeon Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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 K261342 Urocross Expander System (UES-2018-C1)score 11.8 · 2 generations · 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 5…of benign prostatic hyperplasia Regulation Number: 21 CFR 876.5510 Product Code(s) QKA Predicate Device: DEN190020 – iTind System Device Description The Urocross Expander System is a temporary implantable urethral opening system. The U… | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261342 | Urocross Expander System (UES-2018-C1) | 2026 | 0 |
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?
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. 2026, 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 Urocross Expander System is intended to relieve urinary outflow obstruction. The Urocross Expander System is indicated for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH) in men ≥ 45 years old.
The Urocross Expander Implant is indicated for an indwell duration of up to 6 months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253525 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253525: Urocross Expander System (Model Numbers ES2018 and ES3025).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253525
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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