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FDA 510(k)

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)

K-Number: K251442 · 2025-10-02

ApplicantNingbo Tianyi Medical Appliance Co., Ltd.
Decision Date2025-10-02
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) is a medical device manufactured by Ningbo Tianyi Medical Appliance Co., Ltd.. It received FDA 510(k) clearance on 2025-10-02 under approval number K251442. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)?

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) is a medical device that received FDA 510(k) clearance on 2025-10-02. It is manufactured by Ningbo Tianyi Medical Appliance Co., Ltd.. The 510(k) number is K251442.

When was TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) approved by the FDA?

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) received FDA 510(k) clearance on 2025-10-02, under approval number K251442.

What company makes TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)?

TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) is manufactured by Ningbo Tianyi Medical Appliance Co., Ltd..

What is the FDA product code for TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)?

The FDA product code for TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) is FJK.

Related Clinical Trials

NCT06781099 Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis RECRUITING NCT06655142 OSCAR II STUDY - The ONCObind CTC Removal Study NOT_YET_RECRUITING NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING NCT05588011 Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass COMPLETED NCT05011656 Blood Purification for the Treatment of Pathogen Associated Shock ACTIVE_NOT_RECRUITING NCT05399537 Safety Evaluation of Prismocitrate 18 in Patients Receiving CRRT RECRUITING

Other Devices by Ningbo Tianyi Medical Appliance Co., Ltd.

K211025Oral/Enteral Syringe with ENFit connector K210621Oral/Enteral Syringe

Related Devices (Code: FJK)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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