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Tubing, Dialysate (And Connector)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022068

by Molded Products, Inc.

Identifiers

510(k) Number
K022068 FDA 510(k)
FDA Product Code
FID 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 Tubing, Dialysate (And Connector) consists of mechanical accessories designed for use in hemodialysis systems. These devices function by physically coupling dialysate lines to extend tubing length or by connecting dialyzer ports.

The product line includes specific components such as the MPC-725 female-to-female connector and the MPC-740 male-to-male connector. This device is subject to FDA 510(k) authorization under regulation number 876.5820.

Frequently asked questions

What is the primary function of the Molded Products dialysate tubing and connector?

This device is designed for use within hemodialysis systems. It functions as a mechanical accessory to physically couple dialysate lines, allowing for the extension of tubing length or the secure connection of dialyzer ports.

What specific connector models are available in this product line?

The product line includes the MPC-725 female-to-female connector and the MPC-740 male-to-male connector, which are designed to facilitate the necessary physical coupling within the hemodialysis circuit.

What is the regulatory status of this dialysate tubing?

This device is subject to FDA 510(k) authorization under regulation number 876.5820. It was cleared via the traditional 510(k) pathway, with a decision of substantial equivalence reached on September 23, 2002.

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: Molded Products Inc. | Injection Molding | Dialysis Products, Dialysis Machine Parts & Accessories - Molded Products Incorporated, TUBING, DIALYSATE (AND CONNECTOR) (K022068) — FDA 510(k) | Innolitics, MOLDED PRODUCTS, INC. MPC-1010-W Molded Products, Inc. - RevMed, Molded Products, Inc. MPC-774-B "High Temp Female Hansen Connector ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Molded Products, Inc.

Sources (1)

  • FDA 510(k) K022068 24 fields · synced Sep 22, 2026