K251442 is an FDA 510(k) clearance for the TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1). This device is classified as a Set, Tubing, Blood, With And Without Anti-regurgitation Valve (Class II - Special Controls, product code FJK).
Submitted by Ningbo Tianyi Medical Appliance Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on October 2, 2025, 146 days after receiving the submission on May 9, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5820.
| 510(k) Number | K251442 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2025 |
| Decision Date | October 02, 2025 |
| Days to Decision | 146 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJK - Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5820 |