# K973161: Cpap Humidifier (HC 200)

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Electronics, Ltd.
- Decided: Jul 10, 1998 after 322 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: 2 generations back to K952292 (1995). 5 ancestors in all.
110 later devices descend from it; 5 cite it directly.
0 of 116 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961626: Solo Cpap System, Respironics, Inc. (1996) Summary page 1.
- K930656: Sullivan Iii Nasal Cpap System, Rescare, Ltd. (1994) Summary page 1.
- K915460: Heated Respiratory Humidifier HC100, Fisher & Paykel Electronics, Ltd. (1993) Summary page 1.

## Most influential descendants
- K040941: Cpap Humidifier, Model HC234 (and Related Accessories) (2004), 98 descendants of its own
- K041900: HC604 Cpap Humidifier (2004), 74 descendants of its own
- 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

## Indications for use
The Fisher & Paykel Healthcare HC200 CPAP Humidifier is a combined Continuous Positive Airway Pressure Blower and Heated Respiratory Humidifier (as per 73 BZD, 21 CFR §868.5905 and 73 BTT, 21 CFR §868.5450). The HC200 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 the device (normally included as an accessory to CPAP therapy) relieves the drying and irritating effects on the patient airways which may arise from use of a CPAP system. The HC200 is for use on adult, spontaneously breathing (non ventilator-dependent) patients and is a prescription-use device.

Source page: https://510kreport.com/device/K973161
Methodology: https://510kreport.com/methodology