510(k) · Cleared
ClearedUrocross Expander System (UES-2018-C1)
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 Jun 22, 2026 as substantially equivalent to K253525 (Prodeon Medical, Inc., 2026) after a 60-day review. Its family tree reaches back 2 generations to 2020.
- Decided
- Jun 22, 2026
- Review
- 60 days
- Class
- Class II
- Product code
- QKA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN190020 (2020). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K253525 | Urocross Expander System (Model Numbers ES2018 and ES3025)Summary page 5…of benign prostatic hyperplasia Regulation Number: 21 CFR 876.5510 Product Code(s) QKA Predicate Device: K253525 - Urocross Expander System Device Description The Urocross Expander System is a temporary implantable urethral opening system. T… | 2026 |
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 6 years and passes through 2 companies; a new generation was cleared every 6.0 years on median.
- None of the 2 ancestors has a recall.
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/K261342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261342: Urocross Expander System (UES-2018-C1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261342
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026