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CardioBeeper Memory Monitor

by Survival Technology, Inc.

510(k) K813101

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813101 Date27 Nov 1981ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CardioBeeper Memory Monitor is an implantable pacemaker pulse-generator designed to record and store cardiac electrical activity. It functions as a diagnostic tool to capture and retain electrocardiographic data for later retrieval and analysis, aiding in the assessment of arrhythmias and cardiac function.

This device is intended for single-use or reusable applications in a clinical setting, as determined by its regulatory submission. It is classified as a Class III medical device under FDA regulations (870.3610) and has received FDA 510(k) clearance (K813101). The device is not explicitly described as MRI-safe or sterile in the provided data, and no specific storage or handling instructions are noted beyond standard medical device protocols.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the CardioBeeper Memory Monitor in clinical practice?

    The CardioBeeper Memory Monitor is designed to record and store cardiac electrical activity, functioning as a diagnostic tool to capture and retain electrocardiographic (ECG) data. This allows clinicians to retrieve and analyze the data later, which aids in assessing arrhythmias and overall cardiac function.

  • Is the CardioBeeper Memory Monitor intended for single-use or reusable applications?

    The device is explicitly described as intended for either single-use or reusable applications in a clinical setting, depending on how it is configured or handled as determined by its regulatory submission.

  • What regulatory pathway did the CardioBeeper Memory Monitor follow for FDA clearance?

    The device received FDA 510(k) clearance under the traditional review pathway, classified as a Class III medical device (code 870.3610). It was determined to be substantially equivalent to a predicate device, with the clearance number listed as K813101.

  • Are there any specific storage or handling instructions provided for the CardioBeeper Memory Monitor?

    The provided data does not specify any unique storage or handling instructions beyond standard medical device protocols. Clinicians should follow general guidelines for implantable devices unless manufacturer-specific instructions are available.