Skip to content

Thermoprobe 210

by Merced Medical, Inc.

510(k) K900569

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 NumberK900569 Date10 Apr 1990ClearedStatusActive

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  • Withdrawn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
BTT
Device Class
Class II
Regulation
21 CFR Part 868.5450
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 Thermoprobe 210 is a Humidifier, Respiratory Gas (Direct Patient Interface), designed to monitor and maintain temperature within respiratory gas delivery systems. It functions as a temperature-sensing probe to ensure precise thermal regulation during anesthesia or respiratory therapy, helping to prevent complications related to gas conditioning.

This device is intended for single-use in clinical settings, including operating rooms and anesthesia care areas. Supplied sterile, it connects directly to respiratory circuits and requires no additional sterilization. The Thermoprobe 210 adheres to FDA 510(k) clearance (K900569) under the Anesthesiology advisory committee, classified as a Class II medical device under regulation 868.5450. No MRI safety information or reusable specifications are provided.

Other devices from Merced Medical, 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 Thermoprobe 210 used for?

    The Thermoprobe 210 is a temperature-sensing probe designed to monitor and maintain precise thermal regulation within respiratory gas delivery systems. It helps prevent complications related to improper gas conditioning during anesthesia or respiratory therapy by ensuring consistent temperature control in circuits connected directly to patients.

  • Is the Thermoprobe 210 sterile and single-use?

    Yes, the Thermoprobe 210 is supplied sterile and intended for single-use only. This design eliminates the need for additional sterilization procedures, reducing the risk of contamination and ensuring patient safety in clinical settings like operating rooms and anesthesia care areas.

  • How does the Thermoprobe 210 connect to respiratory circuits?

    The Thermoprobe 210 is designed for direct patient interface, meaning it connects straight to respiratory circuits without requiring intermediate adapters or additional components. This streamlined connection ensures accurate temperature monitoring and minimizes potential points of failure or contamination.

  • What regulatory clearance does the Thermoprobe 210 hold?

    The Thermoprobe 210 holds FDA 510(k) clearance under the Anesthesiology advisory committee, classified as a Class II medical device under regulation 868.5450. This clearance confirms its substantial equivalence to a predicate device and compliance with U.S. safety and performance standards for respiratory gas humidifiers.

  • Are there different sizes or models of the Thermoprobe 210?

    The provided data does not specify multiple sizes or models for the Thermoprobe 210. It is described as a singular device with a single-use design, intended for consistent application across anesthesia and respiratory therapy settings. For specific compatibility, verify with the manufacturer that the probe fits your respiratory circuit system.