Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhejiang Chuangxiang Medical Technology Co., Ltd. · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
184 daysmedian FDA review time
255 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253132 | Single use stone retrieval balloons | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-03-06 | 162 | 0 |
| K251890 | Disposable Ureteral Stents | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2026-02-20 | 245 | 0 |
| K230773 | Endoscopy Irrigation Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-11-21 | 245 | 0 |
| K231471 | Air/Water Bottle Tubing, CO2 Source Tubing | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2023-09-08 | 109 | 0 |
| K220063 | Single Use Cytology Brush | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-07-28 | 199 | 0 |
| K212669 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-27 | 277 | 0 |
| K220065 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-05-25 | 135 | 0 |
| K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2022-02-23 | 184 | 0 |
| K191900 | Single Use Grasping Forceps | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2020-03-27 | 255 | 0 |
| K192258 | Disposable Valve Sets | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2019-12-30 | 132 | 0 |
| K173758 | Disposable Biopsy Valve | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-05-14 | 154 | 0 |
| K172762 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-03-20 | 188 | 0 |
| K172758 | Rotatable Snares, Non-Rotatable Snares | Zhejiang Chuangxiang Medical Technology Co., Ltd. | 2018-03-07 | 175 | 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