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TeleTrace Telephone EKG Transmitter #9431

FDA 510(k)

Class II (US FDA 510(k))

510(k) K852971

by Medtronic Vascular

Identifiers

510(k) Number
K852971 FDA 510(k)
FDA Product Code
DXH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2920 FDA 510(k)
Regulation Number
870.2920 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TeleTrace Telephone EKG Transmitter #9431 is a medical device classified as a Transmitters and Receivers, Electrocardiograph, Telephone. It is designed to transmit electrocardiogram (EKG) signals over telephone lines, enabling remote monitoring and communication of cardiac data between patients and healthcare providers.

This device is intended for use in clinical settings where real-time cardiac monitoring is required. Supplied as a reusable medical instrument, it operates within standard telephone infrastructure and adheres to regulatory standards for Class II devices under FDA 510(k) clearance (K852971). Authorized for cardiovascular applications, it was granted Substantially Equivalent (SESE) status in 1985 under regulation 870.2920, with no indication of single-use or sterility requirements.

Frequently asked questions

Is the TeleTrace Telephone EKG Transmitter designed for single-use or can it be reused in clinical settings?

The TeleTrace Telephone EKG Transmitter (#9431) is explicitly described as a reusable medical instrument. There are no sterility requirements or indications of single-use in the provided data, confirming it is intended for repeated use in clinical environments where real-time cardiac monitoring is necessary.

How does this device transmit EKG data, and what infrastructure does it rely on?

The TeleTrace Telephone EKG Transmitter (#9431) is designed to transmit electrocardiogram (EKG) signals over standard telephone lines, enabling remote communication between patients and healthcare providers. It does not require specialized telecommunication hardware beyond existing telephone infrastructure.

What regulatory pathway was followed for FDA clearance of this device, and when was it granted?

The TeleTrace Telephone EKG Transmitter (#9431) received FDA 510(k) clearance under the traditional review pathway, with a Substantially Equivalent (SESE) determination. It was granted clearance on October 22, 1985, under regulation 870.2920 for cardiovascular applications, with the classification of a Class II device.

Are there multiple models or variations of this device, or is it a single-unit solution?

The provided data lists multiple FEI numbers (e.g., 3013689228, 3011265784, etc.), which typically correspond to different lot or batch identifiers rather than distinct models. However, the device is described as a single-unit solution (#9431) without variations in specifications or configurations. These FEI numbers likely reflect regulatory tracking for compliance rather than product variations.

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: #9431 TELETRACE, TELEPHONE, EKG TRANSMITTER (K852971) — FDA 510(k ..., K852971 FDA 510(k) - #9431 TELETRACE | Medtronic Vascular, #9431 Teletrace, Telephone, Ekg Transmitter 510(k)… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K852971 24 fields · synced Sep 20, 2026