Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
142 daysmedian FDA review time
209 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260423 | Disposable Endoscopic Distal Attachments | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2026-05-28 | 108 | 0 |
| K250732 | Disposable Endoscopy Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2025-06-20 | 101 | 0 |
| K230004 | Disposable Hemoclip | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2023-07-31 | 209 | 0 |
| K222980 | Pentax Medical Valve Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-11-21 | 54 | 0 |
| K220785 | Clean Connecting Tube | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-09-27 | 194 | 0 |
| K220292 | Disposable Endoscope Injection Needle | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-08-19 | 199 | 0 |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-06-27 | 102 | 0 |
| K220210 | Disposable Endoscopy Adapter Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 2022-06-17 | 142 | 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