SCT 3000 Heated Humidifier

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K970478 ↗

FDA Product Code

BTT

Device Class

Class II

Regulation

21 CFR Part 868.5450

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Circuit Breathing

  Class I

  FDA 510(k) K840740 Active Cleared 17 Apr 1984

• Dispos. Anesthesia Face Mask

  Class I

  FDA 510(k) K840535 Active Cleared 21 Feb 1984

• Disposable Non-Rebreathing Anes. Circuit

  Class I

  FDA 510(k) K823714 Active Cleared 7 Jan 1983

• Marquest Sct 2000, Heated Humidification System

  Class II

  FDA 510(k) K880979 Active Cleared 15 Jul 1988

• C-CO2 Colorimetric CO2 Indicator

  Class II

  FDA 510(k) K050066 Active Cleared 1 Mar 2005

• Disposable Anesthesia Breathing Circuit

  Class I

  FDA 510(k) K822379 Active Cleared 20 Aug 1982

See all devices from Marquest Medical Products, Inc. →

• What is the primary purpose of the SCT 3000 Heated Humidifier in clinical settings?

  The SCT 3000 Heated Humidifier is designed to condition and deliver heated, humidified gas directly to patients during procedures, particularly in anesthesiology. Its main function is to mitigate risks associated with dry respiratory gas by maintaining airway moisture, which helps prevent potential lung or airway damage.

• Is the SCT 3000 Heated Humidifier intended for single-use or reusable applications?

  The SCT 3000 Heated Humidifier is explicitly described as a reusable medical instrument. It connects to breathing circuits and humidification chambers for consistent gas delivery in clinical environments.

• How is the SCT 3000 Heated Humidifier regulated, and what does that mean for its use?

  The SCT 3000 holds FDA 510(k) clearance under regulation 868.5450, classifying it as a Class II device. This means it has undergone a review process to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for use in anesthesiology settings as intended.

• Are there specific models or variations of the SCT 3000 Heated Humidifier available?

  The provided data lists multiple registration numbers (e.g., 3002807293, 3002808440) associated with the SCT 3000, which may correspond to different models or configurations. These variations are tracked under the same device name and product code (BTT), indicating potential customization for different clinical applications or compatibility with various breathing circuits.

• What type of maintenance or cleaning is required for the SCT 3000 Heated Humidifier?

  Since the SCT 3000 is a reusable device, proper cleaning and maintenance are essential to ensure its functionality and safety. While the data does not specify cleaning protocols, reusable medical devices like this typically require regular disinfection between uses to prevent contamination and maintain performance. Always follow manufacturer guidelines for cleaning and sterilization.