# K241469: iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask

- Pathway: 510(k) (Special)
- Applicant: Sleepnet Corporation
- Decided: Jun 15, 2024 after 22 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: 2 generations back to K021534 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211274: iQ 2 Nasal Mask, Phantom 2 Nasal Mask, Sleepnet Corporation (2022) Summary page 5.

## Indications for use
The iQ 2 Nasal Vented Mask and Phantom 2 Nasal Vented Mask are intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at 3 cmH2O to 30 cmH2O. The masks are to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The masks are intended for single-patient multi-use in the home, hospital or institutional environment.

Source page: https://510kreport.com/device/K241469
Methodology: https://510kreport.com/methodology