Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wuxi Hisky Medical Technologies Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
213 daysmedian FDA review time
268 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250026 | Shear Wave Quantificational Ultrasound Diagnostic System (FH | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-10-01 | 268 | 0 |
| K243711 | Confocal Microprobe Imaging System (BrightP980); Confocal Mi | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-07-24 | 234 | 0 |
| K243880 | Shear Wave Quantificational Ultrasound Diagnostic System (Mi | Wuxi Hisky Medical Technologies Co., Ltd. | 2025-06-17 | 181 | 0 |
| K200136 | Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. | 2020-03-17 | 56 | 0 |
| K173595 | Shear Wave Quantificational Ultrasound Diagnostic System | Wuxi Hisky Medical Technologies Co., Ltd. | 2018-06-22 | 213 | 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