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Breath Tracker Model 1800 Can-O-Gauge

by Core-M, Inc.

510(k) K921978

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 NumberK921978 Date17 Nov 1992ClearedStatusActive

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  • Withdrawn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)

Full name
Breath Tracker(Tm) Model 1800 Can-O-Gauge
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 Model 1800 Can-O-Gauge is a monitor for airway pressure that includes a gauge and/or alarm. It is designed to measure and display airway pressure during medical procedures.

This device is supplied by Core-M, Inc. and is classified under product code CAP as a monitor for airway pressure. It received FDA 510(k) clearance with number K921978 on November 17, 1992, and is intended for use in anesthesiology. The device is not specified as single-use or reusable, and no MRI safety information is provided.

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 Model 1800 Can-O-Gauge used for?

    The Breath Tracker Model 1800 Can-O-Gauge is a monitor for airway pressure that includes a gauge and/or alarm. It is designed to measure and display airway pressure during medical procedures, specifically in anesthesiology.

  • Is the Breath Tracker Model 1800 Can-O-Gauge a single-use device?

    The device is not specified as single-use or reusable in the provided information. Users should consult the manufacturer's instructions for specific guidance on reuse or disposal.

  • What regulatory approvals does the Breath Tracker Model 1800 Can-O-Gauge have?

    The Breath Tracker Model 1800 Can-O-Gauge received FDA 510(k) clearance with number K921978 on November 17, 1992. It is classified under product code CAP as a monitor for airway pressure and is intended for use in anesthesiology.

  • How is the Breath Tracker Model 1800 Can-O-Gauge supplied?

    The device is supplied by Core-M, Inc. No specific information about packaging, sizes, or models is provided in the device data.