Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K230514 FDA 510(k)
- FDA Product Code
- KOC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5820 FDA 510(k)
- Regulation Number
- 876.5820 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
These devices are Blood Tubing Lines for Hemodialysis, classified as Accessories, Blood Circuit, Hemodialysis under FDA regulation 876.5820. They are designed as disposable components for hemodialysis systems, facilitating the safe and efficient transfer of blood between the patient and the dialyzer. The tubing sets include essential elements such as blood tubing, drip chambers, infusion lines, pressure monitoring lines, ports, clamps, and filters to ensure proper hemodialysis function.
The Blood Tubing Lines are supplied as single-use, sterile devices intended for use in hemodialysis procedures. They are engineered for compatibility with hemodialysis delivery systems and are regulated under FDA 510(k) clearance (K230514) and the EU Medical Device Directive (MDD). The AL Series (Archloop) features a redesigned venous chamber without pressure monitoring lines, simplifying setup. All components are non-magnetic and suitable for standard hemodialysis environments, with no specific MRI safety restrictions noted.
Frequently asked questions
Are these tubing lines reusable or designed for single-use in hemodialysis procedures?
These Blood Tubing Lines for Hemodialysis (AL Series and C18 Series) are explicitly designed as single-use, sterile devices. They are intended for one-time use in hemodialysis procedures to ensure patient safety and prevent contamination, aligning with standard medical practice for disposable hemodialysis components.
What key components are included in the Blood Tubing Lines for Hemodialysis, and how do they function?
The tubing sets include blood tubing, drip chambers, infusion lines, pressure monitoring lines (in C18 Series only), ports, clamps, and filters. These components work together to facilitate safe blood transfer between the patient and dialyzer, monitor pressure, and allow for infusion or withdrawal of fluids during hemodialysis. The AL Series simplifies setup by omitting pressure monitoring lines.
How are these devices regulated, and what does that mean for clinical use?
These devices are regulated under FDA 510(k) clearance (K230514) and the EU Medical Device Directive (MDD). The FDA classification is Accessories, Blood Circuit, Hemodialysis (876.5820), and they are deemed substantially equivalent to predicate devices. This means they meet FDA safety and performance standards for hemodialysis tubing, ensuring clinical reliability and compliance with regulatory requirements.
Are there any special considerations for storage or handling of these tubing lines?
While the provided data does not specify storage conditions, as single-use, sterile devices, they should be stored in a clean, dry environment protected from contamination, moisture, or extreme temperatures. Always follow manufacturer guidelines (NIKKISO) for optimal shelf life and sterility preservation, as improper storage could compromise device integrity.
Do these tubing lines have any restrictions for use in environments with MRI machines?
The data states the tubing lines are non-magnetic and do not have specific MRI safety restrictions noted. However, standard precautions should still be followed when using medical devices near MRI equipment, as the presence of metallic components elsewhere in the system could pose risks. Always verify compatibility with the entire hemodialysis setup.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing ..., Archloop - Information site for medical professionals | Nikkiso Co., Ltd., BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230514 | Class II | Active |
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Manufacturer
- Manufacturer
- Nikkiso Co., Ltd.
Sources (2)
- FDA 510(k) K230514 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 29, 2026