# K092256: Thera- Heat Heated Humidifier, Model RC70000, RC70072, RC70075, RC70077, RC70012

- Pathway: 510(k) (Traditional)
- Applicant: Smiths Medical Asd, Inc.
- Decided: Oct 20, 2010 after 449 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: 6 generations back to K913368 (1992). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071958: Thera-Heat Heated Humidifier and  Adult Dual and Single Limb Heated Wire Ventilator Breathing Circuits, Smiths Medical Asd, Inc. (2007) Summary page 1.
- K073706: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2008) Summary page 1.
- K000697: Modification to Airlife Heated Ventilator and Anesthesia Breathing Circuits, Allegiance Healthcare Corp. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K091368: R2 Digitalnow HD (Digitalnow HD), Hologic, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K122705: Humicare D900 (2013), 1 descendant of its own
- K133766: Humicare D900 (2014), 0 descendants of its own

## Indications for use
The Smiths Medical Thera-Heat™ Heated Humidifier 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-Heat™ Heated Humidifier device is intended for use in hospitals and alternate sites by medically trained healthcare providers. Inspiratoryheated limb A Neonate Ventilator Heated Breathing Circuit is intended to warm breathing gases before they enter a patient's airway when used with the Thera-Heat™ 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. Inspiratory and Expiratory heated limb A Neonate Heated Wire Ventilator 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-Heat™ 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/K092256
Methodology: https://510kreport.com/methodology