Citizen Watch Co., Ltd.: FDA clearances and approvals
Citizen Watch Co., Ltd. has 8 FDA 510(k) clearances (first 1991, latest 2006), across 1 product code in 1 review panel. Median 510(k) review time: 170 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 8 | 8 |
Review panels
- Cardiovascular (8)
Most recent Citizen Watch Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K061161 | BLOOD PRESSURE METER, MODEL CH-311B | DXN | 2006-06-26 | 61 |
| K052046 | BLOOD PRESSURE METER, MODEL CH-432 | DXN | 2005-10-19 | 82 |
| K001244 | BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D | DXN | 2000-09-26 | 161 |
| K984223 | BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 | DXN | 1999-04-28 | 154 |
| K973061 | CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) | DXN | 1998-03-13 | 207 |
| K954547 | CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER | DXN | 1997-04-01 | 550 |
| K923344 | ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR | DXN | 1993-10-07 | 476 |
| K911965 | ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR | DXN | 1991-10-28 | 179 |
Recalls
openFDA lists no recalls under a recalling firm named Citizen Watch Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Citizen Watch Co., Ltd. have?
Citizen Watch Co., Ltd. has 8 FDA 510(k) clearances (first 1991, latest 2006), across 1 product code in 1 review panel.
How long does FDA take to clear Citizen Watch Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Citizen Watch Co., Ltd.'s cleared 510(k)s is 170 days.
What devices does Citizen Watch Co., Ltd. make?
Its most frequent FDA product codes are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 8).
Has Citizen Watch Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Citizen Watch Co., Ltd. Related entities may recall under other names.
Next steps
- See all 8 Citizen Watch Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Citizen Watch Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.