Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Koelis — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
184 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180970 | Disposable guides KDNG00 | Koelis | 2018-07-10 | 88 | 0 |
| K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD r | Koelis | 2017-07-31 | 116 | 0 |
| K170521 | TRINITY/3D PROSTATE SUITE | Koelis | 2017-05-30 | 97 | 0 |
| K160357 | TRINITY | Koelis | 2016-05-02 | 84 | 0 |
| K141334 | REUSABLE GUIDE | Koelis | 2014-07-11 | 51 | 0 |
| K131448 | 3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION | Koelis | 2013-07-26 | 67 | 0 |
| K100793 | UROSTATION 3D PROSTATE SUITE | Koelis | 2010-09-22 | 184 | 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