# K231380: AirLife DuoTherm™ Humidification System

- Pathway: 510(k) (Traditional)
- Applicant: Vyaire Medical, Inc.
- Decided: Aug 10, 2023 after 90 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K913368 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033710: MR850 Respiratory Humidifier, Model MR850JHU, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 6.

## Indications for use
The AirLife DuoTherm™ Heated Humidifier is intended to add moisture to, and to warm, the breathing gases for administration to a patient. Gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract, or desiccate secretions of patients whose supraglottic airways have been bypassed. This product is non-sterile, reusable, and intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients ranging from neonates to adults using a heated humidifier. The product is a single use device, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Neonate Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Neonate Heated-Wire Circuits are used with a pediatric population, specifically the neonate (birth to 28 days) and infant (29 days to 2 years) pediatric subgroups with an ideal body weight of 0.5 to 8kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Neonate Heated-Wire Circuits are used for flow rates greater than 1 LPM. The product is single patient use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Pediatric Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Pediatric Heated-Wire Circuits are used with the pediatric patient population, specifically infant (29 days to 2 years) and children (2 years to 12 years) with an ideal body weight of 6 to 42kg that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Pediatric Heated-Wire Circuits are used for flow rates greater than 2 LPM. The product is single use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Adult Heated-Wire Circuits are intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire Circuits are used with the adult population and pediatric population, specifically those with an ideal body weight of 30kg or above, that requires mechanical ventilation, positive pressure breathing or general medical gases, respectively. The Adult Heated-Wire Circuits are used for flow rates greater than 3 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner. The AirLife DuoTherm™ Adult Heated-Wire NIV Circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The Adult Heated-Wire NIV Circuit is used with the spontaneously breathing adult population (>21 years), specifically those with an ideal body weight of 30kg or above, that benefit from high flow therapy. The Adult Heated-Wire NIV Circuits are used for flow rates greater than 5 LPM. The product is single-use, non-sterile, and used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

Source page: https://510kreport.com/device/K231380
Methodology: https://510kreport.com/methodology