Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Olympus Optical, Co. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990687 | HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS | Olympus Optical, Co. | 1999-03-26 | 25 | 0 |
| K982610 | OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY | Olympus Optical, Co. | 1998-11-16 | 112 | 0 |
| K971340 | OLYMPUS NEURO ENDOSCOPE | Olympus Optical, Co. | 1998-07-29 | 475 | 0 |
| K962952 | OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU) | Olympus Optical, Co. | 1996-11-29 | 122 | 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