510(k) · Cleared
ClearedIQ Nasal Mask, Model 50160 Rev. D
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 Jul 2, 2002 after a 53-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Jul 2, 2002
- Review
- 53 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceK021534 IQ Nasal Mask, Model 50160 Rev. DSleepnet Corporation · 2002
- Descendant · cites it directly · 2 of its ownK102317 IQ Ventilation Nasal MaskSleepnet Corporation · 2011
- Descendant · cites it directly · 1 of its ownK211274 iQ 2 Nasal Mask, Phantom 2 Nasal MaskSleepnet Corporation · 2022 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK241469 iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskSleepnet Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK203601 Innova Nasal Non-Vented MaskSleepnet Corporation · 2021
- Descendant · 2 generations on · 0 of its ownK121321 Hard Shell Vented Nasal MaskSleepnet Corporation · 2012
Class I recalls in this family
- K211274 iQ 2 Nasal Mask, Phantom 2 Nasal Maskcites it directly · 2022
Most influential descendants
Showing 5 of 5 · See all- K102317IQ Ventilation Nasal MaskSleepnet Corporation · 2011 · cites it directly2descendants
- K211274iQ 2 Nasal Mask, Phantom 2 Nasal MaskSleepnet Corporation · 2022 · cites it directly1descendant
- K241469iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented MaskSleepnet Corporation · 2024 · 2 generations on0descendants
- K203601Innova Nasal Non-Vented MaskSleepnet Corporation · 2021 · 2 generations on0descendants
- K121321Hard Shell Vented Nasal MaskSleepnet Corporation · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021534 | IQ Nasal Mask, Model 50160 Rev. D | Sleepnet Corporation | 2002 | — |
| +1 | K102317 | IQ Ventilation Nasal Mask | Sleepnet Corporation | 2011 | — |
| +1 | K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal Mask | Sleepnet Corporation | 2022 | Class I |
| +2 | K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | Sleepnet Corporation | 2024 | — |
| +2 | K203601 | Innova Nasal Non-Vented Mask | Sleepnet Corporation | 2021 | — |
| +2 | K121321 | Hard Shell Vented Nasal Mask | Sleepnet Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 1 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211274iQ 2 Nasal Mask, Phantom 2 Nasal MaskSleepnet Corporation · 2022 · Cites it directly · ◆ in the 2022 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K102317 (Sleepnet Corporation, 2011) has gone furthest, with 2 descendants of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021534: IQ Nasal Mask, Model 50160 Rev. D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021534
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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