Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sejoy Electronics & Instruments Co., Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
153 daysmedian FDA review time
228 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161577 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | 2017-02-08 | 246 | 0 |
| K153149 | Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-41 | Sejoy Electronics & Instruments Co., Ltd. | 2016-05-27 | 210 | 0 |
| K153146 | Infrared Ear Thermometer | Sejoy Electronics & Instruments Co., Ltd. | 2016-03-31 | 153 | 0 |
| K152426 | Wrist - Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | 2015-11-09 | 75 | 0 |
| K152687 | Arm-Type Fully Automatic Digital Blood Pressure Monitor | Sejoy Electronics & Instruments Co., Ltd. | 2015-10-16 | 28 | 0 |
| K150545 | Arm-Type Fully Automatic Digital Blood Pressure Monitor (BP- | Sejoy Electronics & Instruments Co., Ltd. | 2015-04-02 | 30 | 0 |
| K141755 | ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Sejoy Electronics & Instruments Co., Ltd. | 2014-11-19 | 142 | 0 |
| K120554 | ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WRI | Sejoy Electronics & Instruments Co., Ltd. | 2012-08-10 | 169 | 0 |
| K121355 | WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR | Sejoy Electronics & Instruments Co., Ltd. | 2012-07-18 | 75 | 0 |
| K110776 | DIGITAL THERMOMETER MT SERIES | Sejoy Electronics & Instruments Co., Ltd. | 2011-08-24 | 156 | 0 |
| K082192 | INFRARED EAR THERMOMETER, MODEL ET-101A | Sejoy Electronics & Instruments Co., Ltd. | 2008-09-17 | 44 | 0 |
| K080789 | BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP | Sejoy Electronics & Instruments Co., Ltd. | 2008-04-03 | 14 | 0 |
| K062784 | SEJOY DIGITAL THERMOMETER, MT SERIES (MT-201, MT-301, MT-402 | Sejoy Electronics & Instruments Co., Ltd. | 2007-05-04 | 228 | 0 |
| K051699 | SEJOY, MODEL MT-403 | Sejoy Electronics & Instruments Co., Ltd. | 2006-02-06 | 227 | 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