# K190533: Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: Jul 26, 2019 after 144 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K936047 (1995). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented, Sleepnet Corporation (2007) Summary page 4.

## Most influential descendants
- K241520: Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask (2024), 0 descendants of its own

## Recalls of this device
- Mar 1, 2024 · Class I · Z-1355-2024: Update to contraindications and warning language due to CPAP masks containing magnets.
- Mar 1, 2024 · Class I · Z-1354-2024: Update to contraindications and warning language due to CPAP masks containing magnets.

## Indications for use
The Sleepnet Mojo 2 and Veraseal 3 Non-Vented and AAV Non-Vented Full Face Masks are intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multi-use version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. Veraseal 3 - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional) Mojo 2 - Single patient, multi-use (home or hospital/institutional)

Source page: https://510kreport.com/device/K190533
Methodology: https://510kreport.com/methodology