Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EZO — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
102 daysmedian FDA review time
664 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000905 | URETHROTOME 8667.XXX AND 8670.XXX | Richard Wolf Medical Instruments Corp. | 2000-05-12 | 52 | 0 |
| K950719 | OES UROLOGY | Olympus America, Inc. | 1996-12-11 | 664 | 0 |
| K945686 | KARL STORZ KNIVES, CURETTES | KARL STORZ Endoscopy-America, Inc. | 1995-02-13 | 84 | 0 |
| K934730 | KARL STORZ ENDOSCOPIC COLD KNIFE BLADES | KARL STORZ Endoscopy-America, Inc. | 1994-01-11 | 102 | 0 |
| K904939 | FLEXIBLE AND RIGID URETEROTOME SYSTEM | Olympus Corp. | 1992-01-07 | 432 | 1 |
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