Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aomori Olympus Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
330 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042160 | SONOSURG TROCAR | Aomori Olympus Co., Ltd. | 2005-01-25 | 168 | 0 |
| K041566 | SONOSURG ULTRASONIC SURGICAL SYSTEM | Aomori Olympus Co., Ltd. | 2004-09-08 | 90 | 0 |
| K033333 | SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-2 | Aomori Olympus Co., Ltd. | 2003-11-14 | 29 | 0 |
| K031523 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Aomori Olympus Co., Ltd. | 2003-10-01 | 139 | 0 |
| K031710 | OLYMPUS ULTRASONIC SURGICAL SYSTEM | Aomori Olympus Co., Ltd. | 2003-08-29 | 88 | 0 |
| K021672 | PANCREATIC DRAINAGE TUBE | Aomori Olympus Co., Ltd. | 2003-04-16 | 330 | 0 |
| K022446 | MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C | Aomori Olympus Co., Ltd. | 2003-03-28 | 246 | 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