Conchatherm LHF Humidifier Heater

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

510(k) Number

K834151 ↗

FDA Product Code

BTT

Device Class

Class II

Regulation

21 CFR Part 868.5450

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Aquapak Prefilled Humidifier

  Class II

  FDA 510(k) K780562 Active Cleared 27 Apr 1978

• Addi-Mist

  Class II

  FDA 510(k) K760964 Active Cleared 9 Dec 1976

• Slimb Single Limb Breathing Circuit

  Class I

  FDA 510(k) K832453 Active Cleared 27 Oct 1983

• Circapak

  Class I

  FDA 510(k) K792268 Active Cleared 27 Nov 1979

• Nebulizer Adapter

  Class II

  FDA 510(k) K772348 Active Cleared 3 Jan 1978

• A Quapak

  Class II

  FDA 510(k) K811073 Active Cleared 29 Apr 1981

See all devices from Respiratory Care, Inc. →

• What is the Conchatherm LHF Humidifier Heater used for?

  The Conchatherm LHF Humidifier Heater is designed to add moisture and warmth to respiratory gases during patient administration. It ensures optimal gas hydration in clinical environments where precise control of humidity is critical, such as operating rooms or intensive care units. This helps maintain comfort and safety for patients undergoing inhalation therapy or anesthesia.

• Is the Conchatherm LHF Humidifier Heater reusable or single-use?

  The Conchatherm LHF Humidifier Heater is supplied as a reusable medical instrument. This design allows for repeated use in clinical settings, provided proper cleaning, maintenance, and sterilization protocols are followed. Reusability helps reduce waste and costs while ensuring consistent performance.

• What regulatory approval does the Conchatherm LHF Humidifier Heater hold?

  The Conchatherm LHF Humidifier Heater holds FDA 510(k) clearance under the reference number K834151. This clearance indicates that the device has been deemed substantially equivalent to a legally marketed predicate device and meets applicable regulatory standards. The device was reviewed by the Anesthesiology Advisory Committee and adheres to 21 CFR 868.5450.

• How is the Conchatherm LHF Humidifier Heater supplied?

  The Conchatherm LHF Humidifier Heater is supplied as a reusable device, meaning it is intended for multiple uses in clinical settings. While the device itself is reusable, associated consumables or disposable components (if applicable) may vary by model and should be checked with the manufacturer for specific details. Proper maintenance and cleaning procedures are essential to ensure safe and effective reuse.

• Is there any specific information about sterility or MRI safety for the Conchatherm LHF Humidifier Heater?

  The available data for the Conchatherm LHF Humidifier Heater does not provide explicit details regarding sterility or MRI safety. For clinical use, it is important to follow manufacturer guidelines for cleaning, sterilization, and maintenance to ensure safe operation. If MRI compatibility is required, additional verification with the manufacturer or regulatory documentation may be necessary.