Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hitachi Aloka Medical America, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152126 | UST-5550-R; UST-5536-R; L43K | Hitachi Aloka Medical America, Inc. | 2016-08-17 | 383 | 0 |
| K153421 | HI VISION ASCENDUS, HV ASCENDUS, ASCENDUS | Hitachi Aloka Medical America, Inc. | 2016-01-21 | 57 | 0 |
| K142618 | Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diag | Hitachi Aloka Medical America, Inc. | 2014-10-16 | 30 | 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