CardioBeeper IV

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K890461 ↗

FDA Product Code

DXH

Device Class

Class II

Regulation

21 CFR Part 870.2920

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• CardioBeeper Memory Monitor

  Class III

  FDA 510(k) K813101 Active Cleared 27 Nov 1981

• Cardiobeeper II

  Class II

  FDA 510(k) K883843 Active Cleared 9 Nov 1988

• Cardiobeeper Memory Monitor Cb 600 Series

  Class II

  FDA 510(k) K894799 Active Cleared 3 Oct 1989

• Stat-Scan

  Class II

  FDA 510(k) K822093 Active Cleared 21 Sep 1982

• Cardiobeeper Profile Monitor

  Class II

  FDA 510(k) K844966 Active Cleared 8 Feb 1985

• Cardiobeeper(R) Cb-Iia

  Class II

  FDA 510(k) K925535 Active Cleared 28 Jan 1993

See all devices from Survival Technology, Inc. →

• What clinical setting is the CardioBeeper IV designed for, and how does it differ from traditional ECG monitoring?

  The CardioBeeper IV is designed for remote cardiac monitoring in both clinical and home settings. Unlike traditional ECG machines that require direct patient connection to a stationary device, this system transmits electrocardiographic (ECG) data in real-time via telephone lines. It allows healthcare providers to continuously or periodically receive heart rate and rhythm information, enabling early detection of cardiac abnormalities and facilitating timely clinical intervention without the need for constant on-site monitoring.

• Is the CardioBeeper IV intended for single-use or reusable applications, and what considerations should be made for its use?

  The CardioBeeper IV is specified as suitable for either single-use or reusable applications, as noted in its regulatory submission. If reused, proper cleaning and maintenance protocols must be followed to ensure patient safety and device functionality. However, the regulatory data does not explicitly detail sterility requirements, so users should refer to manufacturer guidelines for reprocessing procedures if reuse is intended.

• What regulatory pathway was used for the FDA clearance of the CardioBeeper IV, and what does this mean for its compliance?

  The CardioBeeper IV was cleared via the Traditional 510(k) pathway under FDA classification DXH (Transmitters and Receivers, Electrocardiograph, Telephone) and was granted clearance (K890461) in 1989. This means the device was determined to be *substantially equivalent* to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness. No third-party involvement was noted in the submission, and it is classified as a Class II device under regulation 870.2920.

• How can I verify the authenticity or traceability of a CardioBeeper IV unit, and what FEI numbers should I look for?

  The CardioBeeper IV includes multiple FEI (Facility Establishment Identifier) numbers for traceability, such as 3013689228, 3011265784, and others listed in the regulatory data. These numbers help verify the device’s origin and ensure it was manufactured by Survival Technology, Inc. When purchasing, confirm the unit’s FEI number matches the manufacturer’s listed identifiers to avoid counterfeit or mislabeled devices. Always cross-reference with the manufacturer’s documentation for full authenticity.

• Does the CardioBeeper IV require any special storage conditions, and can it be used in environments with electromagnetic interference?

  The regulatory data does not specify size-specific storage instructions or mention electromagnetic interference compatibility for the CardioBeeper IV. However, as a medical device transmitting ECG data, it should be stored in a clean, dry environment protected from physical damage. For electromagnetic interference, users should consult the manufacturer’s instructions to ensure proper functionality, as telephone-line transmission may be affected by external electromagnetic sources.