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Breath Tracker

by Core-M, Inc.

510(k) K892942

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 NumberK892942 Date23 Jun 1989ClearedStatusActive

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  • Withdrawn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
CAP
Device Class
Class II
Regulation
21 CFR Part 868.2600
Advisory Committee
Anesthesiology
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 Breath Tracker is a Monitor, Airway Pressure device, classified as a Class II medical device under FDA regulation 868.2600. It is designed to measure and display airway pressure in real-time, aiding in the monitoring of respiratory parameters during anesthesia and critical care procedures. The device incorporates gauges and alarms to provide visual and auditory feedback to clinicians, ensuring patient safety by alerting to deviations in airway pressure.

This device is intended for use in clinical settings such as operating rooms, intensive care units, and emergency departments. Supplied as a reusable medical instrument, it requires proper sterilization and maintenance per manufacturer guidelines. The Breath Tracker adheres to FDA clearance (510(k) K892942) and is regulated under the Anesthesiology advisory committee. No specific MRI safety classification or single-use designation is stated in the available data.

Other devices from Core-M, Inc.

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 Breath Tracker used for?

    The Breath Tracker is a Class II medical device designed to measure and display airway pressure in real-time. It aids clinicians in monitoring respiratory parameters during anesthesia and critical care procedures, such as in operating rooms, intensive care units, and emergency departments. The device provides visual and auditory feedback through gauges and alarms, helping to alert clinicians to deviations in airway pressure and ensuring patient safety.

  • Is the Breath Tracker a single-use or reusable device?

    The Breath Tracker is supplied as a reusable medical instrument. As such, it requires proper sterilization and maintenance following the manufacturer’s guidelines to ensure safe and effective use across multiple procedures.

  • What regulatory approval does the Breath Tracker hold?

    The Breath Tracker holds FDA clearance under the 510(k) pathway, specifically with clearance number K892942. It is classified under FDA regulation 868.2600 and is intended for use in anesthesia-related applications, as reviewed by the Anesthesiology Advisory Committee.

  • Does the Breath Tracker have any specific MRI safety classification?

    The available data does not specify an MRI safety classification for the Breath Tracker. Clinicians should verify compatibility with their MRI systems before use in environments where MRI procedures are performed.

  • How should the Breath Tracker be stored?

    Since the Breath Tracker is reusable, it must be stored in a clean, dry environment following sterilization procedures. Proper storage ensures the device remains functional and safe for subsequent use. Always adhere to the manufacturer’s guidelines for storage and maintenance to avoid contamination or damage.