Identifiers
- 510(k) Number
- K220106 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The QardioArm 2 is a non-invasive blood pressure monitor (Device Type: DXN) designed for automated, cuff-based measurement of systolic and diastolic blood pressure. It operates wirelessly and includes arrhythmia detection, alerting users to irregular heart rhythms during readings. The device is intended for home or clinical use to provide continuous monitoring of cardiovascular parameters.
Supplied as a single-use or reusable device (sterility not specified), the QardioArm 2 is intended for use in environments where blood pressure assessment is required. It is FDA-cleared under 510(k) K220106 as substantially equivalent to predicate devices, with no noted MRI safety restrictions. Storage conditions are not specified in the regulatory data. The device is manufactured by Qardio, Inc., based in San Francisco, CA.
Frequently asked questions
What is the QardioArm 2 used for?
The QardioArm 2 is a non-invasive blood pressure monitor designed to measure systolic and diastolic blood pressure automatically. It is intended for use in both home and clinical settings to provide continuous cardiovascular monitoring. The device also includes arrhythmia detection, alerting users to irregular heart rhythms during readings, which helps in assessing overall heart health.
Is the QardioArm 2 single-use or reusable?
The QardioArm 2 is supplied as either a single-use or reusable device, though the regulatory data does not specify sterility requirements. If used in clinical settings, proper cleaning and maintenance protocols should be followed to ensure accuracy and hygiene, especially if the device is intended for reuse.
What are the key features that distinguish the QardioArm 2?
The QardioArm 2 stands out due to its wireless functionality, allowing for convenient and automated blood pressure measurements without the need for wired connections. Additionally, it includes built-in arrhythmia detection, which differentiates it from basic blood pressure monitors by providing real-time alerts for irregular heart rhythms, enhancing its utility for cardiovascular monitoring.
Does the QardioArm 2 have any MRI safety restrictions?
The regulatory data for the QardioArm 2 does not mention any specific MRI safety restrictions. However, since it is a wireless blood pressure monitor with electronic components, it is generally recommended to avoid using it near MRI machines unless explicitly stated otherwise by the manufacturer. Always confirm with Qardio, Inc. before use in an MRI environment.
How is the QardioArm 2 regulated in the U.S.?
The QardioArm 2 is FDA-cleared under the 510(k) process with the clearance number K220106. It was determined to be substantially equivalent to predicate devices within the cardiovascular category, ensuring it meets regulatory standards for safety and effectiveness as a non-invasive blood pressure monitor.
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: QardioArm 2 - Smart Blood Pressure Monitor, Qardio: QardioArm 2 - amazon.com, QardioArm 2 - Smart Blood Pressure Monitor
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220106 | Class II | Active |
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Manufacturer
- Manufacturer
- Qardio, Inc.
Sources (1)
- FDA 510(k) K220106 24 fields · synced Oct 1, 2026