ASA BLOOD TUBING LINES— 510(k) K854271

Name: FDA 510(k) clearance K854271
Creator: U.S. Food and Drug Administration
Published: 1985-11-05

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K854271 for ASA BLOOD TUBING LINES, Substantially Equivalent on 1985-11-05. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1985-10-23
Decision date: 1985-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oklahoma City, OK, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FJK

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K243607 — Moda-flx Hemodialysis System Cartridge (102121-001 )2024-12-20
K213992 — CombiSet Hemodialysis Blood Tubing Set2023-05-31

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K000378 — BACT/ALERT MB CULTURE BOTTLE2000-03-02
K994343 — BACT/ALERT SV2000-02-10
K993423 — BACT/ALERT SA1999-12-15

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.