Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PSV · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Olympus Medical Systems Corp. | 2019-09-06 | 261 | 1 |
| K070983 | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USE | Olympus Medical Systems Corporation | 2007-07-05 | 90 | 2 |
| K021204 | OLYMPUS BF TYPE UM40 | Olympus Optical Co., Ltd. | 2002-05-01 | 15 | 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