Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Citizen Systems Japan Co., Ltd. · 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) |
|---|---|---|---|---|---|
| K102303 | BLOOD PRESSURE METER, MODEL CH-658 | Citizen Systems Japan Co., Ltd. | 2010-09-10 | 25 | 0 |
| K100055 | BLOOD PRESSURE METER, MODEL CH-609 | Citizen Systems Japan Co., Ltd. | 2010-08-30 | 234 | 0 |
| K093931 | BLOOD PRESSURE METER, MODEL CH-4532 | Citizen Systems Japan Co., Ltd. | 2010-06-10 | 170 | 0 |
| K100553 | BLOOD PRESSURE METER MODEL CH-101 | Citizen Systems Japan Co., Ltd. | 2010-05-25 | 88 | 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