Heater, Immersion W/ Humidifier & Nebul.

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K760037 ↗

FDA Product Code

BTT

Device Class

Class II

Regulation

21 CFR Part 868.5450

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Manifold & Nebu. for Single Line Mach.

  Class II

  FDA 510(k) K772071 Active Cleared 15 Nov 1977

• Pediatric Anesthesia Circuit

  Class I

  FDA 510(k) K770549 Active Cleared 30 Mar 1977

• Filter, Bacteria (#2290)

  Class II

  FDA 510(k) K760081 Active Cleared 15 Jul 1976

• Inspiron Liquid Oxygen System

  Class II

  FDA 510(k) K834290 Active Cleared 4 Feb 1984

• Cannula, Nasal, for Oxygen

  Class I

  FDA 510(k) K760080 Active Cleared 15 Jul 1976

• Vapor-Phase Humidifier Sys-Advanced

  Class II

  FDA 510(k) K843932 Active Cleared 18 Oct 1984

See all devices from Inspiron Corp. →

• What is the Inspiron immersion heater with humidifier and nebulizer used for?

  This device is designed to condition respiratory gases by maintaining precise temperature and humidity levels during procedures like anesthesia or respiratory therapy. The immersion heater ensures accurate thermal control, while the integrated nebulizer delivers aerosolized medication or hydration directly into the gas stream, improving therapeutic outcomes in clinical settings such as operating rooms or anesthesia suites.

• Is the Inspiron immersion heater reusable or single-use?

  The device is supplied as a reusable medical instrument. It requires proper cleaning, sterilization, and maintenance per manufacturer guidelines to ensure safety and functionality over multiple uses. Reusability is standard for this type of equipment in clinical environments where durability and repeated use are essential.

• What safety considerations should be taken into account when using this device?

  The heater operates within defined MRI safety parameters, though compatibility with specific MRI systems should be verified with facility protocols. Additionally, since it is reusable, strict adherence to cleaning, sterilization, and maintenance procedures is critical to prevent contamination and ensure reliable performance. Always follow manufacturer instructions and institutional protocols for safe operation.

• What regulatory approval does this device hold?

  The Inspiron immersion heater with humidifier and nebulizer is authorized for use in the United States under FDA 510(k) clearance (K760037). This clearance indicates that the device meets regulatory standards outlined in 21 CFR 868.5450 for respiratory therapy equipment, ensuring its safety and effectiveness for intended clinical use.

• How does the nebulization feature enhance patient care?

  The integrated nebulizer delivers aerosolized medication or hydration directly into the respiratory gas stream, which can improve the efficacy of treatments by ensuring consistent and precise administration. This is particularly useful in anesthesia and respiratory therapy settings where maintaining optimal gas conditions is critical for patient safety and therapeutic outcomes.