Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Combei Technology Co., Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202741 | Infrared Forehead Thermometer | Shenzhen Combei Technology Co., Ltd. | 2021-07-07 | 292 | 0 |
| K181104 | Arm type Blood Pressure Monitor, Digital Blood Pressure Moni | Shenzhen Combei Technology Co., Ltd. | 2018-08-29 | 125 | 0 |
| K171833 | Digital Blood Pressure Monitor-Wrist Style | Shenzhen Combei Technology Co., Ltd. | 2018-01-10 | 205 | 0 |
| K163606 | Digital Blood Pressure Monitor-Automatic Upper Arm Style | Shenzhen Combei Technology Co., Ltd. | 2017-05-09 | 139 | 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