# K251920: Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Dcstar, Inc.
- Decided: May 21, 2026 after 332 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: 7 generations back to K936047 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241830: Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask, Sleepnet Corporation (2024) Summary page 5.

## Indications for use
The sleep apnea breathing therapy mask is a non-invasive accessory used for channeling airflow 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.

Source page: https://510kreport.com/device/K251920
Methodology: https://510kreport.com/methodology