BIOTEQUE HEMODIALYSIS BLOOD TUBING SET— 510(k) K992930

Name: FDA 510(k) clearance K992930
Creator: U.S. Food and Drug Administration
Published: 2000-02-09

Substantially Equivalent

Bioteque Corp.

FDA 510(k) clearance K992930 for BIOTEQUE HEMODIALYSIS BLOOD TUBING SET, Substantially Equivalent on 2000-02-09. Applicant: Bioteque Corp.. Device class: 2.

Clearance details

Applicant: Bioteque Corp.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1999-08-31
Decision date: 2000-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flaggstaff, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FJK

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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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K033862 — BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK2005-02-14
K033210 — BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET2004-12-30
K032292 — BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX2004-03-22

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.