# K190254: Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: Jul 5, 2019 after 148 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (1 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). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120463: Mojo, Veraseal, Sleepnet Corporation (2012) Summary page 4.

## Most influential descendants
- K241661: Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask (2024), 0 descendants of its own

## Recalls of this device
- Mar 1, 2024 · Class I · Z-1353-2024: Update to contraindications and warning language due to CPAP masks containing magnets.

## Indications for use
The Sleepnet Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, and V3 Full Face Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O. The masks are to be used on adult patients (>30 kg.) for whom positive airway pressure therapy has been prescribed. Veraseal 3 Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional) V3 Single patient, multi-use (home) Mojo 2 Single patient, multi-use (home or hospital/institutional)

Source page: https://510kreport.com/device/K190254
Methodology: https://510kreport.com/methodology