# K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: May 17, 2007 after 146 days
- Product code: CBK (Ventilator, Continuous, Facility Use)
- Device class: 2
- Regulation: 21 CFR 868.5895
- 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). 13 ancestors in all.
6 later devices descend from it; 3 cite it directly.
3 of 20 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 1.
- K062019: Respcare Hybrid NE Face Mask, Model TBD,; Disposable, Model TBD, Innomed Technologies, Inc./Respcare, Inc. (2006) Summary page 1.

## Most influential descendants
- K102317: IQ Ventilation Nasal Mask (2011), 2 descendants of its own
- 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 (2019), 1 descendant of its own
- 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
- K203601: Innova Nasal Non-Vented Mask (2021), 0 descendants of its own
- K121321: Hard Shell Vented Nasal Mask (2012), 0 descendants of its own

## Recalls of this device
- Mar 1, 2024 · Class I · Z-1352-2024: Update to contraindications and warning language due to CPAP masks containing magnets.

## Indications for use
The Sleepnet MoJoTM-NV Full Face Mask is 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 multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation. (Applies to the standard version): For homecare applications, the Sleepnet MoJoTM-NV Full Face Mask, Nonvented may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients. (Applies to the disposable version): The Sleepnet MoJoTM-NV Full Face Mask, Nonvented Disposable is a single patient, single use interface.

Source page: https://510kreport.com/device/K063806
Methodology: https://510kreport.com/methodology