Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Zhejiang Curaway Medical Technology Co., Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
266 daysmedian FDA review time
336 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K244018 | Disposable Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-07-22 | 207 | 0 |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 | 217 | 0 |
| K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025-01-24 | 171 | 0 |
| K240758 | Radiofrequency Generator System, Cura RF Electrode | Zhejiang Curaway Medical Technology Co., Ltd. | 2024-12-11 | 266 | 0 |
| K232505 | Endovenous Radiofrequency Generator, Endovenous Radiofrequen | Zhejiang Curaway Medical Technology Co., Ltd. | 2024-05-30 | 286 | 0 |
| K222001 | Irreversible Electroporation Ablation Generator, Irreversibl | Zhejiang Curaway Medical Technology Co., Ltd. | 2023-06-08 | 336 | 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