K251442

Substantially Equivalent

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

Applicant: Ningbo Tianyi Medical Appliance Co., Ltd.
Product code: FJK
Advisory panel: Gastroenterology, Urology
Date received: 2025-05-09
Decision date: 2025-10-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

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.