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Carnation Ambulatory Monitor

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191000

by Bardy Diagnostics, Inc.

Identifiers

510(k) Number
K191000 FDA 510(k)
FDA Product Code
DSH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2800 FDA 510(k)
Regulation Number
870.2800 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Carnation Ambulatory Monitor is a Recorder, Magnetic Tape, Medical designed for continuous ambulatory electrocardiographic (ECG) monitoring. It is a portable device used to record heart rhythms over extended periods, enabling the detection of arrhythmias or other cardiac abnormalities that may not be apparent during brief clinic visits. Its primary function is to capture and store ECG data for later analysis by healthcare professionals.

This device is intended for single-use and is supplied as a reusable recorder with replaceable magnetic tape cassettes. It is classified as a Class II medical device under FDA regulations (21 CFR 870.2800) and holds a Special 510(k) clearance (K191000) from the FDA’s Cardiovascular (CV) Advisory Committee. The monitor is designed for ambulatory use, allowing patients to wear it comfortably for extended periods, typically over the sternum to optimize P-wave signal capture. Storage and handling follow standard medical device protocols to ensure data integrity and patient safety.

Frequently asked questions

How is the Carnation Ambulatory Monitor intended to be used in a clinical setting and what makes it suitable for extended patient wear?

The Carnation Ambulatory Monitor is designed for continuous ambulatory electrocardiographic (ECG) monitoring, allowing patients to wear it comfortably over the sternum for extended periods—typically days—to capture heart rhythms. Its portable design and placement optimize P-wave signal capture, making it ideal for detecting arrhythmias or cardiac abnormalities that may not appear during brief clinic visits. The device records ECG data on replaceable magnetic tape cassettes, which are then analyzed by healthcare professionals.

Is the Carnation Ambulatory Monitor intended for single-use or reusable applications, and how does this affect its components?

The Carnation Ambulatory Monitor itself is a reusable recorder, but it relies on replaceable magnetic tape cassettes for recording ECG data. This design ensures that the core device remains functional for multiple uses, while the consumable cassettes are intended for single-use, reducing the risk of contamination or data corruption between patients.

What regulatory pathway was followed for the FDA clearance of the Carnation Ambulatory Monitor, and what does this indicate about its classification?

The Carnation Ambulatory Monitor received a Special 510(k) clearance (K191000) through the FDA’s Cardiovascular (CV) Advisory Committee, indicating it was determined to be substantially equivalent to a predicate device. It is classified as a Class II medical device under FDA regulations (21 CFR 870.2800), which reflects its role in capturing critical cardiac data for diagnostic purposes.

Are there specific storage or handling instructions provided for the Carnation Ambulatory Monitor to ensure data integrity and patient safety?

While the provided data does not specify exact storage conditions, standard medical device protocols should be followed to maintain data integrity and patient safety. This typically includes protecting the device from physical damage, extreme temperatures, and electromagnetic interference, as well as ensuring proper handling of the reusable recorder and replaceable magnetic tape cassettes to prevent contamination or corruption of recorded ECG data.

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: Ambulatory Patch Heart Monitor | Bardy Diagnostics, Ambulatory ECG Monitoring Solutions Made Simple | Bardy Diagnostics, PDF Carnation Ambulatory Monitor (CAM Getting to the Heart of Now FDA ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bardy Diagnostics, Inc.

Sources (1)

  • FDA 510(k) K191000 24 fields · synced Oct 6, 2026