Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Shenzhen Sino-K Medical 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) |
|---|---|---|---|---|---|
| K231961 | NIBPCuff | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-30 | 58 | 0 |
| K223807 | Reusable Temperature Probe, Disposable Temperature Probe | Shenzhen Sino-K Medical Technology Co.,Ltd | 2023-08-25 | 248 | 0 |
| K192608 | Disposable SpO2 Sensor | Shenzhen Sino-K Medical Technology Co.,Ltd | 2020-01-24 | 126 | 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