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A-M Systems ViroMax Viral and Bacterial Filter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063526

by A-M Systems, Inc.

Identifiers

510(k) Number
K063526 FDA 510(k)
FDA Product Code
CAH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5260 FDA 510(k)
Regulation Number
868.5260 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The A-M Systems ViroMax Viral and Bacterial Filter is a breathing-circuit filter designed to remove viral and bacterial contaminants. It features standard ISO 5356-1 coaxial connectors for integration into breathing circuits, scavenging circuits, mechanical ventilation, and manual ventilation applications.

This device is intended for single-patient, single-session use and is supplied in cases of 50 units. It has received FDA 510(k) clearance under the regulation number 868.5260.

Frequently asked questions

What is the intended use of the A-M Systems ViroMax filter?

This device is designed to remove viral and bacterial contaminants from breathing circuits. It is suitable for use in scavenging circuits, mechanical ventilation, and manual ventilation applications.

Is this filter intended for single or multiple use?

The ViroMax filter is intended for single-patient, single-session use only. This ensures the integrity of the filtration performance and prevents cross-contamination between patients.

How is the ViroMax filter integrated into a breathing circuit?

The filter features standard ISO 5356-1 coaxial connectors, which allow for seamless integration into a wide range of breathing circuits and ventilation equipment.

How is this product supplied to facilities?

The A-M Systems ViroMax Viral and Bacterial Filter is supplied in cases containing 50 individual units.

What is the regulatory status of this device?

The A-M Systems ViroMax has received FDA 510(k) clearance under regulation number 868.5260, confirming it has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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: ViroMax Inline Viral & Bacterial Filter - A-M Systems, A-M Systems VIRAL BACTERIAL FILTER | Buy Online - Fisher Sci, ViroMax Bacterial-Viral Filter from A-M Systems, ViroMax Bacterial Viral Filter for Emergency Medical Services

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
A-M Systems, Inc.

Sources (1)

  • FDA 510(k) K063526 24 fields · synced Sep 22, 2026