# K241830: Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: Oct 18, 2024 after 116 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 K936047 (1995). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120463: Mojo, Veraseal, Sleepnet Corporation (2012) Summary page 5.

## Most influential descendants
- K251920: Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask (2026), 0 descendants of its own

## Indications for use
The Sleepnet Mojo Full Face Vented Mask, Veraseal 2 Full Face Vented Mask, Innova Full Face Vented Mask and Ascend Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bilevel, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. Mojo is intended for Single patient, multi-use in the home or hospital/institutional environment. Veraseal 2 is intended for Short Term Single Patient use (maximum of 7 days) in the hospital/institutional environment. Innova is intended for Single patient, multi-use in the home or hospital/institutional environment. Ascend is intended for Single patient, multi-use in the home or hospital/institutional environment.

Source page: https://510kreport.com/device/K241830
Methodology: https://510kreport.com/methodology