FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS— 510(k) K012242

Name: FDA 510(k) clearance K012242
Creator: U.S. Food and Drug Administration
Published: 2001-08-16

Substantially Equivalent

Fresenius Medical Care North America

FDA 510(k) clearance K012242 for FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS, Substantially Equivalent on 2001-08-16. Applicant: Fresenius Medical Care North America. Device class: 2.

Clearance details

Applicant: Fresenius Medical Care North America
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2001-07-17
Decision date: 2001-08-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Lexington, MA, US

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
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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K152953 — CRIT-LINE CLIP (CLIC) BLOOD CHAMBER2015-11-05
K152367 — Optiflux dialyzer2015-10-29
K123262 — OPTIFLUX ULTRA DIALYZER2014-01-06

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.