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Capillary Flow Hollow Fiber Dialyzers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K863044

by National Medical Care, Medical Products Div., Inc.

Identifiers

510(k) Number
K863044 FDA 510(k)
FDA Product Code
FJI 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)

The Capillary Flow Hollow Fiber Dialyzers are Capillary, Hollow Fiber Dialyzers, a class II medical device used for hemodialysis. These devices employ semipermeable hollow fiber membranes to facilitate the exchange of solutes and fluids between the patient’s blood and a dialysate solution, effectively removing waste products and excess fluids from the bloodstream during renal replacement therapy. Their capillary structure enhances surface area for efficient filtration while maintaining mechanical integrity during use.

These dialyzers are supplied as single-use, sterile devices and are intended for use in clinical hemodialysis settings. They are regulated under 21 CFR 876.5820 and cleared via FDA 510(k) submission K863044, with multiple model variants (e.g., Hollow Fiber Dialyzer Focus 90h-r, 120r, 120h-r). Compatibility with standard hemodialysis machines and compliance with Class II regulatory standards ensure safe integration into renal therapy protocols. Storage and handling follow sterile medical device protocols to preserve functionality prior to use.

Frequently asked questions

What are Capillary Flow Hollow Fiber Dialyzers used for?

Capillary Flow Hollow Fiber Dialyzers are designed for hemodialysis, a critical renal replacement therapy. They use semipermeable hollow fiber membranes to remove waste products and excess fluids from the bloodstream by exchanging solutes and fluids between the patient’s blood and a dialysate solution. The capillary structure maximizes surface area for efficient filtration while maintaining durability during use.

Are these dialyzers single-use or reusable?

These dialyzers are supplied as single-use devices. This ensures sterility and safety for each patient, reducing the risk of contamination or cross-infection. Single-use also simplifies storage and handling protocols, as they do not require cleaning or reprocessing between uses.

What models are available for the Capillary Flow Hollow Fiber Dialyzers?

Multiple model variants are available, including the Hollow Fiber Dialyzer Focus 90h-r, 120r, and 120h-r. These models are designed to accommodate different clinical needs and hemodialysis machine compatibilities, ensuring flexibility in renal therapy protocols.

How should these dialyzers be stored before use?

These dialyzers must be stored following sterile medical device protocols to preserve their functionality. They should be kept in their original packaging, protected from moisture, dust, and direct sunlight. Proper storage ensures the integrity of the sterile barrier and the membrane’s performance during hemodialysis.

Are these dialyzers compatible with standard hemodialysis machines?

Yes, these dialyzers are explicitly designed for compatibility with standard hemodialysis machines. Their regulatory clearance and design adhere to Class II standards, ensuring seamless integration into existing renal therapy protocols without requiring additional modifications or adaptations.

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: K863044 FDA 510(k) - CAPILLARY FLOW HOLLOW FIBER DIALYZERS, PDF K863044 - Capillary Flow Hollow Fiber Dialyzers, CAPILLARY FLOW HOLLOW FIBER DIALYZERS 510 (k) K863044 - FDA.report, Capillary Solutions, Hollow Fiber Dialyzer Focus 9or/90h-r/120r/120h-r

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
National Medical Care, Medical Products Div., Inc.

Sources (1)

  • FDA 510(k) K863044 24 fields · synced Oct 1, 2026