# K203601: Innova Nasal Non-Vented Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: Apr 30, 2021 after 142 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). 20 ancestors in all.
No later device cites it as a predicate yet.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102317: IQ Ventilation Nasal Mask, Sleepnet Corporation (2011) Summary page 4.

## Indications for use
The Innova™ Nasal Non-Vented Mask is intended to be used as an accessory to CPAP/bi-level positive pressure systems containing exhalation valves. This product is indicated for use with CPAP/Bi-level systems that have adequate alarms for positive pressure delivery failure. The mask is intended for single patient, multi-use in the home, hospital or institutional environment on adult patients (>30kg/66 lbs.).

Source page: https://510kreport.com/device/K203601
Methodology: https://510kreport.com/methodology