TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)— 510(k) K251442

Name: FDA 510(k) clearance K251442
Creator: U.S. Food and Drug Administration
Published: 2025-10-02

Substantially Equivalent

Ningbo Tianyi Medical Appliance Co., Ltd.

FDA 510(k) clearance K251442 for TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1), Substantially Equivalent on 2025-10-02. Applicant: Ningbo Tianyi Medical Appliance Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ningbo Tianyi Medical Appliance Co., Ltd.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2025-05-09
Decision date: 2025-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code FJK

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K252423 — NovaLine Tubing Set for Hemodialysis (BL 124)2026-05-15
K251341 — VITAL Tubing Sets for Hemodialysis2026-01-16
K243607 — Moda-flx Hemodialysis System Cartridge (102121-001 )2024-12-20
K213992 — CombiSet Hemodialysis Blood Tubing Set2023-05-31
K210782 — Tablo Cartridge2021-11-26

More clearances from Ningbo Tianyi Medical Appliance Co., Ltd.

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K211025 — Oral/Enteral Syringe with ENFit connector2021-06-30
K210621 — Oral/Enteral Syringe2021-04-28

Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.