Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Citizen Watch Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
179 daysmedian FDA review time
550 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061161 | BLOOD PRESSURE METER, MODEL CH-311B | Citizen Watch Co., Ltd. | 2006-06-26 | 61 | 0 |
| K052046 | BLOOD PRESSURE METER, MODEL CH-432 | Citizen Watch Co., Ltd. | 2005-10-19 | 82 | 0 |
| K001244 | BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-6 | Citizen Watch Co., Ltd. | 2000-09-26 | 161 | 0 |
| K984223 | BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 | Citizen Watch Co., Ltd. | 1999-04-28 | 154 | 0 |
| K973061 | CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/ | Citizen Watch Co., Ltd. | 1998-03-13 | 207 | 0 |
| K954547 | CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER | Citizen Watch Co., Ltd. | 1997-04-01 | 550 | 0 |
| K923344 | ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR | Citizen Watch Co., Ltd. | 1993-10-07 | 476 | 0 |
| K911965 | ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR | Citizen Watch Co., Ltd. | 1991-10-28 | 179 | 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