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Omni Patent Monitors

FDA 510(k)

Class II (US FDA 510(k))

510(k) K132229

by Infinium Medical

Identifiers

510(k) Number
K132229 FDA 510(k)
FDA Product Code
MWI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2300 FDA 510(k)
Regulation Number
870.2300 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Omni Patent Monitors are classified as Cardiovascular Monitoring Devices (Product Code MWI) and designed to continuously measure and display vital signs such as ECG, blood pressure, and respiratory parameters in real-time. These monitors provide essential hemodynamic data to assess cardiac function, perfusion, and overall patient stability, supporting clinical decision-making in acute care settings.

Supplied as a reusable device, the Omni Patent Monitors are intended for use in clinical environments requiring reliable cardiovascular monitoring. They are regulated under FDA 510(k) clearance (K132229) and fall under the Cardiovascular (CV) Advisory Committee review. The device is manufactured by Infinium Medical and adheres to traditional clearance pathways, ensuring compliance with U.S. regulatory standards for patient monitoring equipment.

Frequently asked questions

What clinical settings benefit most from the Omni Patent Monitors?

The Omni Patent Monitors are specifically designed for acute care environments where continuous cardiovascular monitoring is critical. They provide real-time data on ECG, blood pressure, and respiratory parameters, enabling clinicians to assess cardiac function, perfusion, and overall patient stability. This is particularly useful in intensive care units, emergency departments, and operating rooms where immediate hemodynamic assessment is essential for clinical decision-making.

How is the Omni Patent Monitors device supplied and intended for use?

The Omni Patent Monitors are supplied as a reusable device, meaning they are intended for repeated use in clinical settings after proper cleaning, disinfection, and maintenance. This design ensures cost-effectiveness and reliability in environments where continuous monitoring is required, such as hospitals and critical care units.

What regulatory pathway does the Omni Patent Monitors follow?

The Omni Patent Monitors are regulated under the FDA’s 510(k) clearance pathway, specifically classified under Product Code MWI (Cardiovascular Monitoring Devices). The device received traditional clearance (K132229) through the Cardiovascular Advisory Committee, ensuring compliance with U.S. regulatory standards for patient monitoring equipment.

Can the Omni Patent Monitors be used for long-term patient monitoring?

While the Omni Patent Monitors are designed for continuous monitoring in acute care settings, their primary purpose is to provide real-time hemodynamic data for short-to-medium-term assessments of patient stability. For long-term monitoring, clinicians should consult additional guidelines or devices tailored to extended use scenarios.

What distinguishes the Omni Patent Monitors from other reusable cardiovascular monitors?

The Omni Patent Monitors stand out due to their integrated real-time measurement of ECG, blood pressure, and respiratory parameters, all displayed simultaneously. This comprehensive hemodynamic data suite supports immediate clinical decision-making, whereas some competitors may offer limited or separate monitoring capabilities. Additionally, its reusable design aligns with cost-efficient clinical workflows.

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: OMNI II™ Touch Screen Patient Monitor - Infinium Medical, OMNI K™ Portable Patient Monitor - Infinium Medical, OMNI II™ Touch Screen Patient Monitor - Infinium Medical, Omni III™ High Acuity Patient Monitor - 15" Display | Infinium Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Infinium Medical

Sources (1)

  • FDA 510(k) K132229 24 fields · synced Oct 1, 2026