Resp. Air Temp. Control & Hazard Mon.

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

510(k) Number

K761295 ↗

FDA Product Code

BZE

Device Class

Class II

Regulation

21 CFR Part 868.5270

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Respiratory Humidifier

  Class II

  FDA 510(k) K761293 Active Cleared 3 Jan 1977

• Jar, Collector for Suction Systems

  Class II

  FDA 510(k) K760333 Active Cleared 27 Oct 1976

• Regulators, Low Suction

  Class II

  FDA 510(k) K760316 Active Cleared 4 Aug 1976

• Respiratory Blower

  Class II

  FDA 510(k) K761294 Active Cleared 3 Jan 1977

• Flowmeter, Oxygen

  Class I

  FDA 510(k) K760314 Active Cleared 4 Aug 1976

• Regulators, High Suction

  Class II

  FDA 510(k) K760317 Active Cleared 4 Aug 1976

• What clinical setting is this device primarily designed for, and how does it improve patient care during procedures?

  This device is designed for use in operating rooms and anesthesia settings, where it regulates the temperature of respiratory air and monitors potential hazards within breathing circuits. By ensuring safe and consistent airflow, it helps maintain optimal conditions for patients undergoing anesthesia or respiratory support, reducing risks like hypothermia or gas leaks during critical procedures.

• Is this device single-use or reusable, and what does that mean for maintenance and cleaning?

  This device is classified as reusable, meaning it is intended for repeated use after proper cleaning, disinfection, and maintenance. Since it’s a reusable Class II medical device, it must follow standard protocols for reprocessing to ensure safety and functionality between uses, including adherence to manufacturer guidelines for cleaning and sterilization.

• How is this device authorized for use in the U.S., and what does that mean for healthcare providers?

  This device holds FDA authorization through a 510(k) clearance (K761295) under regulation 868.5270, meaning it has been deemed substantially equivalent to a legally marketed predicate device. For healthcare providers, this indicates the device meets established safety and performance standards for heater-breathing systems, though they should still follow facility protocols for proper use and maintenance.

• Does this device come with multiple models or sizes, and if so, how might that affect selection for different patients?

  The device is associated with multiple FEI numbers, suggesting it may be available in various configurations or models to accommodate different clinical needs. While the exact specifications aren’t detailed here, the range of registration numbers implies flexibility in sizing or features to ensure compatibility with diverse patient circuits and anesthesia setups. Consulting the manufacturer’s documentation would clarify which model suits specific workflows.

• What storage and handling requirements should be followed to maintain the device’s performance and safety?

  As a reusable medical device, this system must be stored and handled according to standard protocols for reusable equipment, including protection from contamination, physical damage, and environmental extremes. The manufacturer’s instructions should outline specific storage conditions (e.g., temperature, humidity) and handling practices to preserve functionality and ensure long-term reliability in clinical settings.