Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QKA · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261342 | Urocross Expander System (UES-2018-C1) | Prodeon Medical, Inc. | 2026-06-22 | 60 | 0 |
| K253525 | Urocross Expander System (Model Numbers ES2018 and ES3025) | Prodeon Medical, Inc. | 2026-03-12 | 119 | 0 |
| K210138 | iTind System | Medi-Tate , Ltd. | 2021-06-25 | 157 | 0 |
| DEN190020 | iTind System | Medi-Tate , Ltd. | 2020-02-25 | 329 | 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