# K060273: Sleepnet Mojo Full Face Mask -Small, Model NO. 53835, Medium ,Model NO.53836,Large,Model NO. 53837

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: May 2, 2006 after 89 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: 4 generations back to K936047 (1995). 9 ancestors in all.
20 later devices descend from it; 4 cite it directly.
8 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043382: TMS Full Advantage Full Face Mask, Models TMS-2820, TMS-2830, TMS-2840, Tiara Medical Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K132887: Airfit N10 (2013), 7 descendants of its own
- K153673: AirFit N20 (2016), 6 descendants of its own
- K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented (2007), 6 descendants of its own
- K161978: AirFit N20 (2016), 5 descendants of its own
- K120463: Mojo, Veraseal (2012), 4 descendants of its own

## Indications for use
The Sleepnet MoJoTM Full Face Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H20 for the treatment of adult obstructive sleep apnea. The mask is intended for single patient use and reuse in the home or hospital institutional environment. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed.

Source page: https://510kreport.com/device/K060273
Methodology: https://510kreport.com/methodology