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Audicor CPAM with SDB (Cardiopulmonary Ambulatory Monitor with Sleep Disordered Breathing Detection)

by Inovise Medical, Inc.

510(k) K120462

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK120462 Date20 Sep 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 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  • Withdrawn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
MLO
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Audicor CPAM with SDB is an ambulatory electrocardiograph designed for continuous or intermittent monitoring of cardiac and respiratory parameters. It records electrocardiogram (ECG) signals, heart sounds, sleep-disordered breathing events, snoring, and activity levels to assess cardiopulmonary function during daily activities or extended wear periods.

This device is intended for single-use and is supplied as a portable, battery-powered unit with disposable sensors. It operates in non-MRI environments and is cleared by the FDA under 510(k) classification (K120462) as an ambulatory electrocardiograph with analysis algorithms (product code MLO). Storage and handling follow standard medical device protocols to ensure data integrity and patient safety.

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Questions

AI-generated answers, 1 Oct 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 Audicor CPAM with SDB used for?

    The Audicor CPAM with SDB is designed for continuous or intermittent monitoring of cardiac and respiratory parameters. It records electrocardiogram (ECG) signals, heart sounds, sleep-disordered breathing events, snoring, and activity levels. This allows clinicians to assess cardiopulmonary function during daily activities or extended wear periods, helping diagnose or evaluate conditions related to the heart and breathing.

  • How is the Audicor CPAM with SDB supplied?

    The Audicor CPAM with SDB is supplied as a portable, battery-powered unit paired with disposable sensors. This setup ensures ease of use and reduces the risk of cross-contamination between patients, aligning with single-use medical device standards.

  • Is the Audicor CPAM with SDB intended for single-use or reuse?

    The Audicor CPAM with SDB is explicitly designed for single-use. This design choice minimizes infection risks and ensures data integrity, as reusable devices may require rigorous cleaning and sterilization protocols that could compromise sensor performance or patient safety.

  • Can this device be used in MRI environments?

    No, the Audicor CPAM with SDB is intended for use in non-MRI environments only. The device’s components, including sensors and electronics, are not MRI-compatible, and exposure to MRI fields could cause malfunctions or pose safety risks to patients.

  • What regulatory clearance does the Audicor CPAM with SDB hold?

    The Audicor CPAM with SDB is cleared by the FDA under the 510(k) classification (K120462) as an ambulatory electrocardiograph with analysis algorithms. This clearance confirms that the device meets FDA standards for safety and effectiveness as a substantially equivalent device to predecessors in the market.