# K120463: Mojo, Veraseal

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: Jul 27, 2012 after 163 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: 5 generations back to K936047 (1995). 21 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060273: Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837, Sleepnet Corporation (2006) Summary page 2.
- K063122: Mirage Quattro Full Face Mask, Resmed, Ltd. (2007) Summary page 2.

## Most influential descendants
- K241830: Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask (2024), 1 descendant of its own
- K190254: Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask (2019), 1 descendant of its own
- K251920: Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask (2026), 0 descendants of its own
- 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-1351-2024: Update to contraindications and warning language due to CPAP masks containing magnets.

## Indications for use
The SleepNet Mojo and Veraseal masks are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2 0. The masks are to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. Veraseal - Disposable single use (hospital/institutional) Single patient, multi-use up to 7 days (hospital/institutional) Mojo - Single patient, multi-use (home or hospital/institutional)

Source page: https://510kreport.com/device/K120463
Methodology: https://510kreport.com/methodology