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Airway Temperature Sensor

by Mon-A-Therm, Inc.

510(k) K821505

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 NumberK821505 Date9 Dec 1982ClearedStatusActive

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  • Withdrawn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
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Airway Temperature Sensor is a device used to measure temperature in the airway. It is a Class 2 device with product code GEI, and is substantially equivalent to other devices. The device is used for temperature measurement, and is part of a broader line of temperature probes and sensors.

The Airway Temperature Sensor is supplied by Mon-A-Therm, Inc. and has been cleared through the Traditional 510(k) pathway with FDA clearance number K821505. The device is intended for use in multiple clinical settings, including the operating room and intensive care areas. It is a single-use or reusable device, but the data does not specify. The device has a FDA 510(k) clearance.

Other devices from Mon-A-Therm, Inc.

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Questions

AI-generated answers, 26 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 Airway Temperature Sensor used for?

    The Airway Temperature Sensor is used to measure temperature in the airway, and is intended for use in multiple clinical settings, including the operating room and intensive care areas.

  • Is the Airway Temperature Sensor single-use or reusable?

    The data does not specify whether the Airway Temperature Sensor is single-use or reusable, it is recommended to consult the manufacturer's instructions for use.

  • What is the regulatory status of the Airway Temperature Sensor?

    The Airway Temperature Sensor has been cleared through the Traditional 510(k) pathway with FDA clearance number K821505, and is considered substantially equivalent to other devices.