Skip to content

TMM Model 2500 CapMonitor

by Traverse Medical Monitors

510(k) K875268

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 NumberK875268 Date22 Jan 1988ClearedStatusActive

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  • Withdrawn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
CCK
Device Class
Class II
Regulation
21 CFR Part 868.1400
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 TMM Model 2500 CapMonitor is a capnograph designed to monitor and display exhaled carbon dioxide (CO₂) concentrations during anesthesia. As a member of the anesthesia monitoring category, it provides real-time capnography readings to assist clinicians in assessing ventilation efficacy, endotracheal tube placement, and respiratory function in patients under anesthesia.

This device is intended for use in operating rooms and anesthesia care settings. Supplied as a reusable medical instrument, it requires proper maintenance and calibration to ensure accurate readings. The TMM Model 2500 CapMonitor holds an FDA 510(k) clearance under K875268, classified under product code CCK, and was reviewed by the Anesthesiology Advisory Committee. No sterility or single-use specifications are indicated in the regulatory data.

Other devices from Traverse Medical Monitors