RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET— 510(k) K014140

Name: FDA 510(k) clearance K014140
Creator: U.S. Food and Drug Administration
Published: 2002-11-18

Substantially Equivalent

Sunder Biomedical Tech. Co., Ltd.

FDA 510(k) clearance K014140 for RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET, Substantially Equivalent on 2002-11-18. Applicant: Sunder Biomedical Tech. Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sunder Biomedical Tech. Co., Ltd.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2001-12-17
Decision date: 2002-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taichung City, TW

Download summary PDF View on FDA.gov ↗

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K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)2025-10-02
K243607 — Moda-flx Hemodialysis System Cartridge (102121-001 )2024-12-20
K213992 — CombiSet Hemodialysis Blood Tubing Set2023-05-31

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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.