Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210435 | Automatic Arm Electronic Blood Pressure Monitor | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021-05-12 | 89 | 0 |
| K202776 | Fingertip pulse oximeter | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021-03-01 | 161 | 0 |
| K202687 | Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 | Shenzhen Lepu Intelligent Medical Equipment Co., Ltd. | 2021-02-18 | 156 | 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