# K953392: HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Electronics, Ltd.
- Decided: Mar 12, 1996 after 237 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.
74 later devices descend from it; 2 cite it directly.
4 of 77 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.
- K913367: Models MR410 & MR480 Respiratory Humidifier/Access, Fisher & Paykel Electronics, Ltd. (1992) Summary page 1.

## Most influential descendants
- K983112: Respiratory Humidifier, Model # MR850 (1998), 73 descendants of its own
- K020332: Respiratory Humidifier, Model MR850 (2003), 65 descendants of its own
- K033710: MR850 Respiratory Humidifier, Model MR850JHU (2004), 54 descendants of its own
- K073706: Respiratory Humidifier, Model MR850 (2008), 47 descendants of its own
- K092846: Airvo Series Humidifiers (2010), 30 descendants of its own

## Indications for use
The intended use of the HC500 is to provide therapeutic levels of heat and humidity to a patient's inspired respiratory gases, when using an artificial ventilation system. This includes use with systems such as portable volume ventilation systems, pressure support ventilation and continuous positive airway pressure (CPAP) devices. These systems may bypass the patient airway (using an endotracheal tube) or use mask ventilation. Providing heat and humidification to these gases counteracts the effects of bypassing the nose, pharynx and trachea, where this function would normally be carried out by the body. Addition of heat and humidity to the supply of cold and dry respiratory gases provided through mask ventilation is similarly beneficial to prevent drying of the patient airways. The HCS500 is primarily intended for a home-use situation, typically for patients requiring long-term respiratory assistance of a non-critical nature (ie not requiring hospital or intensive care levels of attention).

Source page: https://510kreport.com/device/K953392
Methodology: https://510kreport.com/methodology