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RT Carbon ECG Leads

FDA 510(k)

Class II (US FDA 510(k))

510(k) K240087

by Ivy Biomedical Systems, Inc.

Identifiers

510(k) Number
K240087 FDA 510(k)
FDA Product Code
DSA FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2900 FDA 510(k)
Regulation Number
870.2900 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The RT Carbon ECG Leads are a type of Cable, Transducer, and Electrode, Patient (Including Connector), designed for electrocardiographic monitoring. These leads facilitate the transmission of electrical signals from ECG electrodes placed on a patient to an ECG monitoring device, enabling accurate cardiac rhythm assessment during diagnostic procedures.

These leads are intended for use in X-ray imaging environments and connect between patient electrodes and an ECG trunk cable. They are reusable, nonsterile, and compatible with adult, pediatric, and neonatal patients. The device is classified under FDA regulation number 870.2900 and holds a 510(k) clearance (K240087) for substantial equivalence in the cardiovascular category.

Frequently asked questions

Are these ECG leads reusable or single-use, and how does that affect their use in X-ray environments?

The RT Carbon ECG Leads are designed as reusable, nonsterile devices. Their reusable nature allows for repeated use in X-ray imaging environments, which is explicitly noted in the device description. However, since they are nonsterile, they should only be used in non-invasive procedures where sterility is not required, such as routine ECG monitoring during X-ray imaging. Proper cleaning and maintenance between uses are essential to ensure accuracy and reliability.

What patient populations can these ECG leads be used with, and are there any size-specific considerations?

The RT Carbon ECG Leads are compatible with all patient populations, including adult, pediatric, and neonatal patients. The device description does not specify size-specific models, so they appear to be designed for general use across these populations. However, clinicians should ensure proper electrode placement and secure attachment to the patient’s skin to maintain signal integrity.

How should these ECG leads be stored, and are there any special handling instructions?

The device data does not specify storage conditions explicitly, but as reusable, nonsterile leads, they should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of electrical interference. Since they are used in X-ray environments, they should also be protected from radiation exposure during storage. Follow manufacturer guidelines for cleaning and maintenance to preserve functionality.

What regulatory pathway was followed for FDA clearance, and what does that mean for buyers?

The RT Carbon ECG Leads received FDA clearance through a 510(k) Traditional Review process, classified under FDA regulation number 870.2900 and assigned the product code DSA. The clearance (K240087) was granted under the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device. This means the device meets FDA requirements for safety and effectiveness as a reusable ECG cable/transducer/electrode system for electrocardiographic monitoring, including use in X-ray environments.

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: RT Carbon ECG Leads by Ivy Biomedical Systems, Inc. | FDA 510 (k) Summary, RT Carbon ECG Leads (K240087) — FDA 510 (k) | Innolitics, RT Carbon ECG Leads (K240087) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ivy Biomedical Systems, Inc.

Sources (1)

  • FDA 510(k) K240087 24 fields · synced Sep 18, 2026