Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sein Electronics Co., Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
190 daysmedian FDA review time
513 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052108 | SEIN BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM, MODEL | Sein Electronics Co., Ltd. | 2005-12-07 | 126 | 0 |
| K042138 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 | Sein Electronics Co., Ltd. | 2004-08-24 | 15 | 0 |
| K042014 | DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND | Sein Electronics Co., Ltd. | 2004-08-06 | 10 | 0 |
| K032927 | FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR | Sein Electronics Co., Ltd. | 2004-05-07 | 228 | 0 |
| K012054 | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL SE-312 | Sein Electronics Co., Ltd. | 2001-08-08 | 37 | 0 |
| K003711 | AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25 | Sein Electronics Co., Ltd. | 2000-12-15 | 14 | 0 |
| K003282 | FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H | Sein Electronics Co., Ltd. | 2000-11-01 | 13 | 0 |
| K991397 | TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR SE-30 TENS | Sein Electronics Co., Ltd. | 2000-02-11 | 296 | 0 |
| K973078 | WRIST BLOOD PRESSURE METER MODEL SE-330 | Sein Electronics Co., Ltd. | 1999-05-20 | 640 | 0 |
| K952827 | FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 | Sein Electronics Co., Ltd. | 1996-11-14 | 513 | 0 |
| K952826 | FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000 | Sein Electronics Co., Ltd. | 1996-11-14 | 513 | 0 |
| K912588 | AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS | Sein Electronics Co., Ltd. | 1991-12-19 | 190 | 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