Sein Electronics Co., Ltd.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Sein Electronics Co., Ltd.” (first 1991, latest 2005), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 158 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 | 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 | 9 | 9 |
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| NBW | System, Test, Blood Glucose, Over The Counter | 1 | 1 |
Review panels
- Cardiovascular (10)
- Clinical Chemistry (1)
- Neurology (1)
Most recent Sein Electronics Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K052108 | SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL BGP-100 | NBW | 2005-12-07 | 126 |
| K042138 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 | DXN | 2004-08-24 | 15 |
| K042014 | DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400 | DXN | 2004-08-06 | 10 |
| K032927 | FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR | DXN | 2004-05-07 | 228 |
| K012054 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 | DXN | 2001-08-08 | 37 |
| K003711 | AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P | DXN | 2000-12-15 | 14 |
| K003282 | FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H | DXN | 2000-11-01 | 13 |
| K991397 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS | GZJ | 2000-02-11 | 296 |
| K973078 | WRIST BLOOD PRESSURE METER MODEL SE-330 | DPW | 1999-05-20 | 640 |
| K952827 | FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 | DXN | 1996-11-14 | 513 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sein Electronics 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sein Electronics Co., Ltd.?
FDA lists 12 510(k) clearances under the applicant name “Sein Electronics Co., Ltd.” (first 1991, latest 2005), across 4 product codes in 3 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 Sein Electronics Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sein Electronics Co., Ltd. is 158 days.
Which FDA product codes appear under Sein Electronics Co., Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 9); DPW (Flowmeter, Blood, Cardiovascular, 1); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1).
Next steps
- See all 12 Sein Electronics Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Sein Electronics 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.