NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693— 510(k) K072024

Name: FDA 510(k) clearance K072024
Creator: U.S. Food and Drug Administration
Published: 2007-10-04

Substantially Equivalent

Nipro Medical Corp.

FDA 510(k) clearance K072024 for NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693, Substantially Equivalent on 2007-10-04. Applicant: Nipro Medical Corp.. Device class: 2.

Clearance details

Applicant: Nipro Medical Corp.
Product code: Code FJK
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2007-07-24
Decision date: 2007-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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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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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 →

Recalls naming K072024

K-number listed on FDA's recall record

Z-1876-2018 — Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.Class II·Terminated·Nipro Medical Corporation·20171219

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072024.

Data sourced from openFDA. This site is unofficial and independent of the FDA.