# K121321: Hard Shell Vented Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: Nov 30, 2012 after 212 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: 7 generations back to K936047 (1995). 23 ancestors in all.
No later device cites it as a predicate yet.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092835: Comfortgel Nasal Mask, Respironics Inc., Sleep & Home Respiratory Group (2010) Summary page 1.
- K102317: IQ Ventilation Nasal Mask, Sleepnet Corporation (2011) Summary page 1.

## Indications for use
The Hard Shell Vented Nasal Mask is intended to provide an interface for application of positive airway pressure therapy, such as CPAP or bi-level. The mask is intended for: Single use, disposable Single patient, multi-use in the home setting Multi-patient, multi-use in the hospital or institutional settings Single patient, short-term use (up to 7 days) in the hospital or institutional settings The masks are to be used on adult patients (>66 lbs. / >30 kg) for whom CPAP or bi-level therapy has been prescribed.

Source page: https://510kreport.com/device/K121321
Methodology: https://510kreport.com/methodology