Telemetry Decoder

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K801339 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K791568 Active Cleared 19 Sep 1979

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  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Telemetry Decoder from Intermedics, Inc. and how does it integrate with existing medical systems?

  The Telemetry Decoder is designed to receive, process, and interpret wireless telemetry signals from implantable pacemaker pulse generators. It enables clinicians to remotely monitor and assess patient heart rhythms by decoding cardiac data transmitted from these implanted devices. Since it operates in conjunction with implantable pacemakers, it serves as a critical link between the patient’s implanted device and clinical monitoring systems, facilitating remote patient management in cardiovascular care.

• Is the Telemetry Decoder a single-use or reusable device, and what does this mean for maintenance and cost considerations?

  The Telemetry Decoder is supplied as a reusable medical instrument, which means it is intended for repeated use across multiple patients. This design reduces single-patient costs and allows for proper maintenance and sterilization protocols to be implemented between uses. Reusability also implies that facilities will need to establish cleaning and disinfection procedures to ensure device integrity and patient safety over time.

• What regulatory pathway was followed for the FDA clearance of this device, and which advisory committee was involved?

  The Telemetry Decoder received FDA 510(k) clearance under the Traditional pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device to demonstrate substantial equivalence. The device was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee, which specializes in evaluating cardiovascular-related medical devices, ensuring compliance with regulation number 870.3610.

• Does the Telemetry Decoder come with specific models or sizes, and how might this affect clinical workflows?

  The provided data does not specify distinct models or sizes for the Telemetry Decoder, but it is designed to work with implantable pacemaker pulse generators. Clinicians should confirm compatibility with their specific pacemaker systems during implementation. Since it is a reusable device, workflows should account for setup, calibration, and maintenance routines tailored to the device’s operational requirements.