# K102317: IQ Ventilation Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: May 17, 2011 after 274 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: 6 generations back to K936047 (1995). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 22 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021534: IQ Nasal Mask, Model 50160 Rev. D, Sleepnet Corporation (2002) Summary page 1.
- K063806: Sleepnet Mojo -NV Full Face Mask, Non-Vented, Sleepnet Corporation (2007) Summary page 1.
- K991648: Reusable Contour II Nasal Mask, Respironics, Inc. (1999) Summary page 1.

## Most influential descendants
- K203601: Innova Nasal Non-Vented Mask (2021), 0 descendants of its own
- K121321: Hard Shell Vented Nasal Mask (2012), 0 descendants of its own

## Indications for use
The IQ® Ventilation Nasal Mask is to be used as an accessory to CPAP / hi-level positive pressure systems that have adequate alarms and safety systems for positive pressure delivery failure. Use of this product is indicated for use with CPAP / BI-LEVEL POSITIVE PRESSURE SYSTEMS CONTAINING EXHALATION VALVES. The IQ® Ventilation Nasal mask is intended for single patient, multi-use in the home environment and multiple patients, multi-use in the hospital/institutional environment.

Source page: https://510kreport.com/device/K102317
Methodology: https://510kreport.com/methodology