Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nihon Seimitsu Sokki Co., Ltd. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
248 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112620 | DISITAL BLOOD PRESSURE MONITOR | Nihon Seimitsu Sokki Co., Ltd. | 2012-08-02 | 329 | 0 |
| K112690 | BLOOD PRESSURE MONITOR | Nihon Seimitsu Sokki Co., Ltd. | 2012-02-24 | 162 | 0 |
| K112691 | BLOOD PRESSURE MONITOR | Nihon Seimitsu Sokki Co., Ltd. | 2012-02-24 | 162 | 0 |
| K093102 | AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270 | Nihon Seimitsu Sokki Co., Ltd. | 2010-06-03 | 245 | 0 |
| K080177 | WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV | Nihon Seimitsu Sokki Co., Ltd. | 2008-05-09 | 106 | 0 |
| K071596 | POTABLE AIR MASSAGER PUTIFINO, MODEL AM-7 | Nihon Seimitsu Sokki Co., Ltd. | 2008-02-15 | 248 | 0 |
| K071384 | MODIFICATION TO: DIGITAL BLOOD PRESSURE MONITOR, MODEL 1901 | Nihon Seimitsu Sokki Co., Ltd. | 2007-10-09 | 145 | 0 |
| K061086 | DM-3000 DIGITAL BLOOD PRESSURE MONITOR | Nihon Seimitsu Sokki Co., Ltd. | 2006-08-10 | 114 | 0 |
| K050697 | MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR | Nihon Seimitsu Sokki Co., Ltd. | 2005-03-25 | 7 | 0 |
| K040309 | DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-1862 | Nihon Seimitsu Sokki Co., Ltd. | 2004-02-24 | 15 | 0 |
| K031582 | WRIST BLOOD PRESSURE MONITOR & FAT METER, MODEL WT-20 | Nihon Seimitsu Sokki Co., Ltd. | 2003-08-01 | 72 | 0 |
| K012194 | BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110 | Nihon Seimitsu Sokki Co., Ltd. | 2001-07-20 | 7 | 0 |
| K003444 | MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR | Nihon Seimitsu Sokki Co., Ltd. | 2000-11-21 | 15 | 0 |
| K993890 | DIGITAL BLOOD PRESSURE MONITOR, MODEL DS-181 | Nihon Seimitsu Sokki Co., Ltd. | 1999-12-01 | 15 | 0 |
| K981702 | AUTOMATIC DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR MO | Nihon Seimitsu Sokki Co., Ltd. | 1999-03-05 | 295 | 0 |
| K952494 | DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR | Nihon Seimitsu Sokki Co., Ltd. | 1995-12-28 | 212 | 0 |
| K882635 | ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR | Nihon Seimitsu Sokki Co., Ltd. | 1988-11-09 | 135 | 0 |
| K850318 | UNISONIC ELECTRONIC DIGITAL BP MONITOR EMB-4050 | Nihon Seimitsu Sokki Co., Ltd. | 1985-04-18 | 83 | 0 |
| K850316 | UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-2050 | Nihon Seimitsu Sokki Co., Ltd. | 1985-04-16 | 81 | 0 |
| K850317 | UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-3050 | Nihon Seimitsu Sokki Co., Ltd. | 1985-04-16 | 81 | 0 |
| K850315 | UNISONIC ELECTRONIC DIGITAL BP MONITOR EBM-1050 | Nihon Seimitsu Sokki Co., Ltd. | 1985-04-16 | 81 | 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