# K021534: IQ Nasal Mask, Model 50160 Rev. D

- Pathway: 510(k) (Special)
- Applicant: Sleepnet Corporation
- Decided: Jul 2, 2002 after 53 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K102317: IQ Ventilation Nasal Mask (2011), 2 descendants of its own
- K211274: iQ 2 Nasal Mask, Phantom 2 Nasal Mask (2022), 1 descendant of its own
- K241469: iQ 2 Nasal Vented Mask; Phantom 2 Nasal 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

## Indications for use
The SleepNet Corporation IQ@Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 3 cmH20 for the treatment of adult obstructive sleep apnea.

Source page: https://510kreport.com/device/K021534
Methodology: https://510kreport.com/methodology