Sejoy Electronics & Instruments Co., Ltd.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Sejoy Electronics & Instruments Co., Ltd.” (first 2006, latest 2017), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 148 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 122 |
| 2013 | 0 | — |
| 2014 | 1 | 142 |
| 2015 | 3 | 30 |
| 2016 | 2 | 182 |
| 2017 | 1 | 246 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sejoy Electronics & Instruments Co., Ltd. took a median 246 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 8 | 8 |
| FLL | Continuous Measurement Thermometer | 6 | 6 |
Review panels
- Cardiovascular (8)
- General Hospital (6)
Most recent Sejoy Electronics & Instruments Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K161577 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | DXN | 2017-02-08 | 246 |
| K153149 | Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 | FLL | 2016-05-27 | 210 |
| K153146 | Infrared Ear Thermometer | FLL | 2016-03-31 | 153 |
| K152426 | Wrist - Type Fully Automatic Digital Blood Pressure Monitor | DXN | 2015-11-09 | 75 |
| K152687 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | DXN | 2015-10-16 | 28 |
| K150545 | Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP-1305, BP-1307, BP-1326, BP-1318, BP-1319, BP-1211, BP-1312, BSP-11, BSP-12, BSP-13) | DXN | 2015-04-02 | 30 |
| K141755 | ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | DXN | 2014-11-19 | 142 |
| K120554 | ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | DXN | 2012-08-10 | 169 |
| K121355 | WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | DXN | 2012-07-18 | 75 |
| K110776 | DIGITAL THERMOMETER MT SERIES | FLL | 2011-08-24 | 156 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sejoy Electronics & Instruments Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sejoy Biomedical Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sejoy Electronics & Instruments Co., Ltd.?
FDA lists 14 510(k) clearances under the applicant name “Sejoy Electronics & Instruments Co., Ltd.” (first 2006, latest 2017), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sejoy Electronics & Instruments Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sejoy Electronics & Instruments Co., Ltd. is 148 days.
Which FDA product codes appear under Sejoy Electronics & Instruments Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 8); FLL (Continuous Measurement Thermometer, 6).
Next steps
- See all 14 Sejoy Electronics & Instruments Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Sejoy Electronics & Instruments Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.