510(k) · Cleared
ClearedIQ Nasal Mask, Model P/N 50160
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 Oct 27, 1999 after a 27-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Oct 27, 1999
- Review
- 27 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK993269 IQ Nasal Mask, Model P/N 50160Sleepnet Corporation · 1999
- Descendant · cites it directly · 2 of its ownK022642 Twlight, Model Isp 9600Invacare Corp. · 2003
- Descendant · 2 generations on · 0 of its ownK061874 Invacare's Twilight II Nasal MasksInvacare Corp. · 2006
- Descendant · 2 generations on · 0 of its ownK042455 Devilbiss Nasal Cpap Mask, 9354 SeriesSunrise Medical · 2005
- Descendant · cites it directly · 0 of its ownK041309 Imask TMVital Signs, Inc. · 2004
Most influential descendants
Showing 4 of 4 · See all- K022642Twlight, Model Isp 9600Invacare Corp. · 2003 · cites it directly2descendants
- K061874Invacare's Twilight II Nasal MasksInvacare Corp. · 2006 · 2 generations on0descendants
- K042455Devilbiss Nasal Cpap Mask, 9354 SeriesSunrise Medical · 2005 · 2 generations on0descendants
- K041309Imask TMVital Signs, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993269 | IQ Nasal Mask, Model P/N 50160 | Sleepnet Corporation | 1999 | — |
| +1 | K022642 | Twlight, Model Isp 9600 | Invacare Corp. | 2003 | — |
| +2 | K061874 | Invacare's Twilight II Nasal Masks | Invacare Corp. | 2006 | — |
| +2 | K042455 | Devilbiss Nasal Cpap Mask, 9354 Series | Sunrise Medical | 2005 | — |
| +1 | K041309 | Imask TM | Vital Signs, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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.
Planning a device in BZD? 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? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K022642 (Invacare Corp., 2003) 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 Q™ Nasal Mask is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure) operating at or above 3 cmH₂O for the treatment of adult obstructive sleep apnea.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993269 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993269: IQ Nasal Mask, Model P/N 50160.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993269
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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