Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Bsx Technology Electronics Co., Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
243 daysmedian FDA review time
344 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241578 | Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315 | Shenzhen Bsx Technology Electronics Co., Ltd. | 2025-02-19 | 261 | 0 |
| K230097 | IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103 | Shenzhen Bsx Technology Electronics Co., Ltd. | 2023-04-06 | 83 | 0 |
| K202296 | Infrared Forehead Thermometer, Model BSX976 | Shenzhen Bsx Technology Electronics Co., Ltd. | 2021-07-23 | 344 | 0 |
| K202324 | Fingertip Pulse Oximeter | Shenzhen Bsx Technology Electronics Co., Ltd. | 2020-12-14 | 119 | 0 |
| K183058 | Arm-type Electronic Blood Pressure Monitor | Shenzhen Bsx Technology Electronics Co., Ltd. | 2019-07-03 | 243 | 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