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Reverso

FDA 510(k)

Class II (US FDA 510(k))

510(k) K994306

by Medisystems Corp.

Identifiers

510(k) Number
K994306 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)

The Reverso Flow Reversing Valve is a component of hemodialysis blood circuit accessories, designed to facilitate bidirectional flow within extracorporeal circuits. It functions as a flow reversing valve, enabling controlled reversal of blood flow during hemodialysis procedures to enhance circuit efficiency and safety.

This device is supplied as a reusable accessory for hemodialysis circuits and is intended for use in clinical settings where hemodialysis is performed. It is classified under FDA regulation number 876.5820 and has received FDA 510(k) clearance (K994306). The valve is part of a broader set of components, including connectors and interconnections, and is regulated under Class II medical device standards.

Frequently asked questions

What is the primary purpose of the Reverso Flow Reversing Valve in hemodialysis procedures?

The Reverso Flow Reversing Valve is designed to enable bidirectional blood flow within extracorporeal hemodialysis circuits. It allows controlled reversal of blood flow during dialysis, which helps improve circuit efficiency and enhances safety by reducing potential clotting or air entrapment risks.

Is the Reverso valve reusable or single-use, and how should it be handled between uses?

The Reverso valve is explicitly supplied as a reusable accessory for hemodialysis circuits. Since it is intended for reuse, proper cleaning, disinfection, and maintenance procedures must be followed between uses to ensure sterility and functionality. Medisystems Corp. likely provides guidelines for reprocessing, which should be strictly adhered to in clinical settings.

What regulatory pathway was followed for FDA clearance of the Reverso valve, and what does that mean for its use?

The Reverso valve received FDA 510(k) clearance under the Traditional pathway, with a decision of Substantially Equivalent to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets applicable safety and effectiveness standards for use in hemodialysis circuits. The clearance is tied to FDA regulation number 876.5820, which governs hemodialysis accessories.

How is the Reverso valve integrated into hemodialysis systems, and what components does it pair with?

The Reverso valve is part of a broader set of hemodialysis blood circuit accessories, including connectors and interconnections. It is specifically designed to work within extracorporeal circuits to facilitate flow reversal, ensuring compatibility with standard hemodialysis systems. While it is not a standalone device, its function is critical for maintaining circuit efficiency during dialysis procedures.

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: REVERSO (K994306) — FDA 510 (k) | Innolitics, Reverso Clamp Flow Reversing Interconnector for… - FDA.report, Medisystems Corp. - FDA 510 (k) Cleared Devices, MEDISYSTEMS CORPORATION in California | Company Info & Reviews - Bizapedia, REVERSO 510 (k) K994306 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medisystems Corp.

Sources (1)

  • FDA 510(k) K994306 24 fields · synced Sep 19, 2026