# K071958: Thera-Heat Heated Humidifier and  Adult Dual and Single Limb Heated Wire Ventilator Breathing Circuits

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Nov 21, 2007 after 128 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: 1 generation back to K913368 (1992). 2 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913368: Models MR700/MR720/MR730 Dual Servo Resp Humid Acc, Fisher & Paykel Electronics, Ltd. (1992) Summary page 1.
- K000697: Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits, Allegiance Healthcare Corp. (2000) Summary page 1.

## Most influential descendants
- K100104: Hybernite Rainout Control System (2010), 6 descendants of its own
- K110398: Respironics Disposable Heated Wire Circuits (2011), 3 descendants of its own
- K140424: Respironics Reusable Heated Tubing (2014), 2 descendants of its own
- K092256: Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012 (2010), 2 descendants of its own
- K122705: Humicare D900 (2013), 1 descendant of its own

## Indications for use
The Smiths Medical Thera-HeatTM Heated Humidifier device is intended to warm and add humidity to the breathing gases that are administered to the patient. The humidifier is indicated for patients requiring mechanical ventilation, positive pressure breathing assistance of general medical gases The Smiths Medical Thera-HeatTM Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers. An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-HeatTM Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems. An adult ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway and to warm the breathing gases on return from the patient to the ventilator when used with the Thera-HeatTM Heated Humidifier. The circuit acts as a conduit to warm the gases between the humidification chamber and the patient during mechanical ventilation or positive pressure breathing assistance for use with invasive and non-invasive breathing systems.

Source page: https://510kreport.com/device/K071958
Methodology: https://510kreport.com/methodology