# K150685: Skynector CPAP Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sky Wise Medical Instrument (Shen Zhen) Co., Ltd.
- Decided: Aug 24, 2015 after 160 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: 6 generations back to K982530 (1998). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113127: Mirage Quattro, Resmed, Ltd. (2012) Summary page 6.
- K092835: Comfortgel Nasal Mask, Respironics Inc., Sleep & Home Respiratory Group (2010) Summary page 6.

## Indications for use
The Skynector CPAP Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Skynector CPAP Mask is to be used by adult patients (>661b / >30kg) for whom positive airway pressure has been prescribed. The Skynector CPAP Mask is intended for single patient re-use in the home environment and/or multi-patient reuse in the hospital / institutional environment.

Source page: https://510kreport.com/device/K150685
Methodology: https://510kreport.com/methodology