EXEL I.V. BLOOD LINE SET— 510(k) K992039

Name: FDA 510(k) clearance K992039
Creator: U.S. Food and Drug Administration
Published: 2000-02-10

Substantially Equivalent

Exelint Intl. Co.

FDA 510(k) clearance K992039 for EXEL I.V. BLOOD LINE SET, Substantially Equivalent on 2000-02-10. Applicant: Exelint Intl. Co.. Device class: 2.

Clearance details

Applicant: Exelint Intl. Co.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1999-06-17
Decision date: 2000-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, 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
K243607 — Moda-flx Hemodialysis System Cartridge (102121-001 )2024-12-20
K213992 — CombiSet Hemodialysis Blood Tubing Set2023-05-31

More clearances from Exelint Intl. Co.

view all

K092172 — EXEL I.V. EXTENSION SET2010-01-04
K052103 — EXEL SECURE TOUCH II SAFETY SYRINGE2005-10-19
K031500 — EXCEL PRIMARY SOLUTION SET2003-07-25
K011754 — EXEL SECURETOUCH PTP SYRINGE2003-01-22
K020533 — EXEL VACULET BLOOD COLLECTION SET2002-12-02

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.