Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Uroviu Corporation — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
217 daysmedian FDA review time
267 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253226 | UV5000W Handle | Uroviu Corporation | 2025-10-23 | 24 | 0 |
| K250797 | UV5000 Handle | Uroviu Corporation | 2025-09-11 | 181 | 0 |
| K243196 | Uro-G HD Cystoscope (1520) | Uroviu Corporation | 2024-12-13 | 73 | 0 |
| K232837 | Uro-G HD Flexible Cystoscope | Uroviu Corporation | 2024-06-07 | 267 | 0 |
| K202921 | Uro-G Cystoscope | Uroviu Corporation | 2021-05-04 | 217 | 0 |
| K182876 | Uro-N Cystoscope | Uroviu Corporation | 2019-07-02 | 263 | 0 |
| K171500 | Uro-V Cystoscope | Uroviu Corporation | 2018-01-30 | 252 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda