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Central Venous Pressure Manometer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K904674

by Medex, Inc.

Identifiers

510(k) Number
K904674 FDA 510(k)
FDA Product Code
KRK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1140 FDA 510(k)
Regulation Number
870.1140 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A central venous pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure. It is classified as a Class II medical device under regulation number 870.1140 and is substantially equivalent to a predicate device cleared via the traditional 510(k) pathway.

The device is supplied as part of a set that includes a 4-way stopcock and a 50-inch extension set with a 'Y' site located 34 inches from the male Luer lock, along with 3/4-inch and 1-inch pole clamps. It is manufactured by Medex, Inc. and has FDA 510(k) authorization under K number K904674.

Frequently asked questions

What is the central venous pressure manometer used for?

It is attached to a venous catheter to indicate manometrically the central or peripheral venous pressure, allowing clinicians to monitor fluid status and cardiac function in critically ill patients.

What components are included with the central venous pressure manometer set?

The device is supplied as part of a set that includes a 4-way stopcock, a 50-inch extension set with a 'Y' site located 34 inches from the male Luer lock, and 3/4-inch and 1-inch pole clamps for secure mounting.

Is the central venous pressure manometer sterile and intended for single use?

The device data does not specify sterility or single-use status; however, as a pressure monitoring accessory attached to catheters, it is typically designed for single-patient use to prevent cross-contamination, though reuse may be possible if properly cleaned and sterilized per institutional protocols.

What regulatory pathway was used for the central venous pressure manometer?

The device received FDA 510(k) clearance via the traditional pathway under K number K904674, demonstrating substantial equivalence to a predicate device in the same classification.

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: Medex 35 cm CVP manometer Set: 4-way stopcock and 50" Extension set, 10/Cs, Medex 35 cm CVP manometer Set 4-way stopcock and 50″ Extension set, 10/Cs, CENTRAL VENOUS PRESSURE MANOMETER (K904674) — FDA 510(k) | Innolitics, CVP Manometer - Polymedicure Limited

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medex, Inc.

Sources (1)

  • FDA 510(k) K904674 24 fields · synced Sep 28, 2026