# K211274: iQ 2 Nasal Mask, Phantom 2 Nasal Mask

- Pathway: 510(k) (Traditional)
- Applicant: Sleepnet Corporation
- Decided: Jan 10, 2022 after 258 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021534 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
1 of 3 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 4.

## Most influential descendants
- K241469: iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask (2024), 0 descendants of its own

## Recalls of this device
- Mar 1, 2024 · Class I · Z-1357-2024: Update to contraindications and warning language due to CPAP masks containing magnets.
- Mar 1, 2024 · Class I · Z-1356-2024: Update to contraindications and warning language due to CPAP masks containing magnets.

## Indications for use
The iQ 2 and Phantom 2 Nasal Mask is intended to be used with positive airway pressure devices, such as CPAP or bi-level, operating at or above 3 cm H2O to 30 cm H2O. The mask is to be used on adult patients (>30kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single-patient multi-use in the home, hospital or institutional environment.

Source page: https://510kreport.com/device/K211274
Methodology: https://510kreport.com/methodology