# K203347: Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Yuyue Medical Technology Co., Ltd.
- Decided: Jul 2, 2021 after 231 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: 11 generations back to K982530 (1998). 40 ancestors in all.
No later device cites it as a predicate yet.
4 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170924: AirFit F20, Resmed, Ltd. (2018) Summary page 4.
- K161978: AirFit N20, Resmed, Ltd. (2016) Summary page 4.
- K090244: Swift FX, Resmed, Ltd. (2009) Summary page 4.

## Indications for use
The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow (with or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system. -The mask is to be used by patients (weighing>30kg), intended for single patient reuse in the home environment. -The mask is intended for single-patient use in the hospital or institutional environment.

Source page: https://510kreport.com/device/K203347
Methodology: https://510kreport.com/methodology