Yangzhou Fartley Medical Instrument Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Yangzhou Fartley Medical Instrument Technology Co., Ltd.” (first 2022, latest 2026), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 125 days. Since 2017 the median was 125 days, against 145 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 5 | 142 |
| 2023 | 1 | 209 |
| 2024 | 0 | — |
| 2025 | 1 | 101 |
| 2026 | 1 | 108 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Yangzhou Fartley Medical Instrument Technology Co., Ltd. took a median 125 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ODC | Endoscope Channel Accessory | 3 | 3 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FDI | Snare, Flexible | 1 | 1 |
| OCX | Endoscopic Irrigation/Suction System | 1 | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 | 1 |
Review panels
Most recent Yangzhou Fartley Medical Instrument Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260423 | Disposable Endoscopic Distal Attachments | FDF | 2026-05-28 | 108 |
| K250732 | Disposable Endoscopy Valve Set | ODC | 2025-06-20 | 101 |
| K230004 | Disposable Hemoclip | PKL | 2023-07-31 | 209 |
| K222980 | Pentax Medical Valve Set | ODC | 2022-11-21 | 54 |
| K220785 | Clean Connecting Tube | OCX | 2022-09-27 | 194 |
| K220292 | Disposable Endoscope Injection Needle | FBK | 2022-08-19 | 199 |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare | FDI | 2022-06-27 | 102 |
| K220210 | Disposable Endoscopy Adapter Set | ODC | 2022-06-17 | 142 |
Recalls
openFDA lists no recalls under a recalling firm named Yangzhou Fartley Medical Instrument Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Yangzhou Medline Industry, Co., Ltd. (2 510(k)s)
- Yangzhou Runyi Arts & Crafts Co., Ltd. (1 510(k)s)
- Yangzhou Saraguard Medical Supplies Co., Ltd. (1 510(k)s)
- Yangzhou Wei DE LI Trade Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Yangzhou Fartley Medical Instrument Technology Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Yangzhou Fartley Medical Instrument Technology Co., Ltd.” (first 2022, latest 2026), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Yangzhou Fartley Medical Instrument Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Yangzhou Fartley Medical Instrument Technology Co., Ltd. is 125 days. Since 2017: 125 days, versus 145 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Yangzhou Fartley Medical Instrument Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are ODC (Endoscope Channel Accessory, 3); FBK (Endoscopic Injection Needle, Gastroenterology-Urology, 1); FDF (Colonoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 8 Yangzhou Fartley Medical Instrument Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code ODC, Yangzhou Fartley Medical Instrument Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.