Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Shenzhen Wisonic Medical Technology Co. , Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
190 daysmedian FDA review time
368 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230066 | Carnation series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2023-09-15 | 249 | 0 |
| K211886 | Clivia series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2021-12-02 | 164 | 0 |
| K210154 | Labat series Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2021-07-30 | 190 | 0 |
| K191347 | Paragon XHD Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2020-02-07 | 263 | 0 |
| K182715 | Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2018-11-20 | 54 | 0 |
| K180461 | Navi e/Navi s/Navi X Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2018-05-09 | 78 | 0 |
| K163712 | Clover 50/Clover60/Clover70 Diagnostic Ultrasound System | Shenzhen Wisonic Medical Technology Co. , Ltd. | 2018-01-02 | 368 | 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