Moda-flx Hemodialysis System Cartridge (102121-001 )— 510(k) K243607

Name: FDA 510(k) clearance K243607
Creator: U.S. Food and Drug Administration
Published: 2024-12-20

Substantially Equivalent

Diality, Inc.

FDA 510(k) clearance K243607 for Moda-flx Hemodialysis System Cartridge (102121-001 ), Substantially Equivalent on 2024-12-20. Applicant: Diality, Inc.. Device class: 2.

Clearance details

Applicant: Diality, Inc.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2024-11-21
Decision date: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FJK

view all

K252423 — NovaLine Tubing Set for Hemodialysis (BL 124)2026-05-15
K251341 — VITAL Tubing Sets for Hemodialysis2026-01-16
K251442 — TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)2025-10-02
K213992 — CombiSet Hemodialysis Blood Tubing Set2023-05-31
K210782 — Tablo Cartridge2021-11-26

More clearances from Diality, Inc.

view all

K233798 — Moda-flx Hemodialysis System and Cartridge2024-08-02

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.