510(k) · Cleared
Recalled · Class I · 2024iQ 2 Nasal Mask, Phantom 2 Nasal Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleepnet Corporation · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jan 10, 2022 as substantially equivalent to K021534 (Sleepnet Corporation, 2002) after a 258-day review. Its family tree reaches back 1 generation to 2002. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jan 10, 2022
- Review
- 258 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021534 (2002). 1 later device descends from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK021534 IQ Nasal Mask, Model 50160 Rev. DSleepnet Corporation · 2002
- This deviceK211274 iQ 2 Nasal Mask, Phantom 2 Nasal MaskSleepnet Corporation · 2022
- Descendant · cites it directly · 0 of its ownK241469 iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskSleepnet Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskSleepnet Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021534 | IQ Nasal Mask, Model 50160 Rev. D | Sleepnet Corporation | 2002 | — |
| 0 (this device) | K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal Mask | Sleepnet Corporation | 2022 | — |
| +1 | K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | Sleepnet Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021534 | IQ Nasal Mask, Model 50160 Rev. DSummary page 4…B) Product Code: BZD Regulatory Class: II Device: iQ 2 and Phantom 2 Nasal Mask Predicate Device: K021534 - Sleepnet iQ Nasal mask Regulation Number: 21CFR 868.5905 Regulation Code: Non-continuous ventilator… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | 2024 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2024 | Class I | Z-1357-2024 | Device Design | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Mar 1, 2024 | Class I | Z-1356-2024 | Device Design | Update to contraindications and warning language due to CPAP masks containing magnets. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211274: iQ 2 Nasal Mask, Phantom 2 Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211274
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026