Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Hitachi, Ltd., Health Care Company · 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) |
|---|---|---|---|---|---|
| K153614 | PROBEAT-V and accessories | Hitachi, Ltd., Health Care Company | 2016-04-21 | 126 | 0 |
| K152592 | PROBEAT-V | Hitachi, Ltd., Health Care Company | 2015-11-02 | 53 | 0 |
| K152207 | Extended Range Shifter for PROBEAT-V | Hitachi, Ltd., Health Care Company | 2015-10-02 | 57 | 0 |
| K151132 | PROBEAT-V | Hitachi, Ltd., Health Care Company | 2015-06-01 | 34 | 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