Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Zhengkang Technology 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) |
|---|---|---|---|---|---|
| K213984 | Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) | Shenzhen Zhengkang Technology Co., Ltd. | 2022-12-16 | 361 | 0 |
| K203707 | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-6 | Shenzhen Zhengkang Technology Co., Ltd. | 2021-03-12 | 84 | 0 |
| K191894 | Upper Arm Blood Pressure Monitor | Shenzhen Zhengkang Technology Co., Ltd. | 2020-02-21 | 221 | 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