Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260423Disposable Endoscopic Distal AttachmentsYangzhou Fartley Medical Instrument Technology Co., Ltd.2026-05-281080
K250732Disposable Endoscopy Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.2025-06-201010
K230004Disposable HemoclipYangzhou Fartley Medical Instrument Technology Co., Ltd.2023-07-312090
K222980Pentax Medical Valve SetYangzhou Fartley Medical Instrument Technology Co., Ltd.2022-11-21540
K220785Clean Connecting TubeYangzhou Fartley Medical Instrument Technology Co., Ltd.2022-09-271940
K220292Disposable Endoscope Injection NeedleYangzhou Fartley Medical Instrument Technology Co., Ltd.2022-08-191990
K220790Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Yangzhou Fartley Medical Instrument Technology Co., Ltd.2022-06-271020
K220210Disposable Endoscopy Adapter SetYangzhou Fartley Medical Instrument Technology Co., Ltd.2022-06-171420

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