# K071069: Mini Cpap Device and Humidifier Accessory

- Pathway: 510(k) (Traditional)
- Applicant: Viasys Sleep Systems, LLC
- Decided: Jun 12, 2007 after 57 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052597: Breathex Omega Cpap Device, Model 322, Hoffman Laboratories, LLC (2005) Summary page 1.
- K973161: Cpap Humidifier (HC 200), Fisher & Paykel Electronics, Ltd. (1998) Summary page 1.

## Indications for use
The VIASYS Sleep Systems Mini CPAP device is intended for treatment of obstructive sleep apnea (OSA) in spontaneously breathing adults weighing at least 30 kg. The VIASYS Sleep Systems Mini CPAP device provides continuous positive airway pressure. The Humidifier accessory provides humidification of the air delivered to the patient.

Source page: https://510kreport.com/device/K071069
Methodology: https://510kreport.com/methodology