Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhuhai Pusen Medical Technology Co., Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
232 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260521 | ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PU | Zhuhai Pusen Medical Technology Co., Ltd. | 2026-04-06 | 48 | 0 |
| K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Sin | Zhuhai Pusen Medical Technology Co., Ltd. | 2024-07-16 | 232 | 0 |
| K223741 | Pusen Single Use Flexible Video Cystoscope/Choledochoscope S | Zhuhai Pusen Medical Technology Co., Ltd. | 2023-06-22 | 190 | 0 |
| K222602 | Pusen Single Use Flexible Video Cystoscope System (Single Us | Zhuhai Pusen Medical Technology Co., Ltd. | 2022-09-26 | 28 | 0 |
| K190648 | Pusen Eview Medical Video Endoscope Image Processor | Zhuhai Pusen Medical Technology Co., Ltd. | 2019-03-29 | 16 | 0 |
| K172098 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017-08-31 | 51 | 0 |
| K171076 | Medical Video Endoscope System | Zhuhai Pusen Medical Technology Co., Ltd. | 2017-05-05 | 24 | 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