# K041900: HC604 Cpap Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Aug 31, 2004 after 48 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K952292 (1995). 7 ancestors in all.
74 later devices descend from it; 4 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040941: Cpap Humidifier, Model HC234 (and Related Accessories), Fisher & Paykel Healthcare, Ltd. (2004) Summary page 1.

## Most influential descendants
- K082605: Vpap Auto with Humidaire 3I (2009), 33 descendants of its own
- K091947: S8 Aspen with H4I Plus (2009), 31 descendants of its own
- K092846: Airvo Series Humidifiers (2010), 30 descendants of its own
- K121975: Airvo Humidifier Myairo Humidifier (2013), 25 descendants of its own
- K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier (2013), 24 descendants of its own

## Indications for use
The HC604 CPAP Humidifier is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction. The addition of heated respiratory humidification to this therapy relieves the drying and irritating effects on the patient airways, which may arise from use of a CPAP system. The HC604 CPAP Humidifier is for use on adult, spontaneously breathing (non-ventilator dependant) patients at home or in the sleep laboratory.

Source page: https://510kreport.com/device/K041900
Methodology: https://510kreport.com/methodology