Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhejiang Soudon Medical Technology Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
165 daysmedian FDA review time
231 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253013 | Disposable Stone Retrieval Balloon Catheter | Zhejiang Soudon Medical Technology Co., Ltd. | 2026-05-08 | 231 | 0 |
| K253056 | Disposable Stone Extraction Basket | Zhejiang Soudon Medical Technology Co., Ltd. | 2026-04-03 | 193 | 0 |
| K232450 | Disposable Hemostatic Clips | Zhejiang Soudon Medical Technology Co., Ltd. | 2024-01-26 | 165 | 0 |
| K232442 | Disposable Endoscope Injection Needles | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-09 | 87 | 0 |
| K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-07 | 83 | 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