510(k) · Cleared
ClearedModification to Nasal-Aire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innomed Technologies · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Mar 21, 2003 after a 238-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 20 devices in its family, counting itself, has a Class I recall. 19 later devices descend from it.
- Decided
- Mar 21, 2003
- Review
- 238 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 0
19 later devices descend from it, 8 citing it directly. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- This deviceK022465 Modification to Nasal-AireInnomed Technologies · 2003
- Descendant · cites it directly · 8 of its ownK042130 Aura Cpap Patient InterfaceAeiomed, Inc. · 2004
- Descendant · 2 generations on · 5 of its ownK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
- Descendant · cites it directly · 3 of its ownK031883 Lyra Nasal MaskSensor Medics Corp. · 2003
- Descendant · cites it directly · 2 of its ownK140980 TI Nasal MaskRespironics, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK210844 DreamWear Silicone Pillows MaskRespironics, Inc. · 2021
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K140980 TI Nasal Maskcites it directly · 2015
Most influential descendants
Showing 5 of 19 · See all- K042130Aura Cpap Patient InterfaceAeiomed, Inc. · 2004 · cites it directly8descendants
- K100121Model 300157 Cpap SystemAeiomed, Inc. · 2010 · 2 generations on5descendants
- K031883Lyra Nasal MaskSensor Medics Corp. · 2003 · cites it directly3descendants
- K140980TI Nasal MaskRespironics, Inc. · 2015 · cites it directly2descendants
- K210844DreamWear Silicone Pillows MaskRespironics, Inc. · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022465 | Modification to Nasal-Aire | Innomed Technologies | 2003 | — |
| +1 | K042130 | Aura Cpap Patient Interface | Aeiomed, Inc. | 2004 | — |
| +2 | K100121 | Model 300157 Cpap System | Aeiomed, Inc. | 2010 | — |
| +1 | K031883 | Lyra Nasal Mask | Sensor Medics Corp. | 2003 | — |
| +1 | K140980 | TI Nasal Mask | Respironics, Inc. | 2015 | Class I |
| +2 | K210844 | DreamWear Silicone Pillows Mask | Respironics, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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? (19)
See all 198 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042130 | Aura Cpap Patient Interface | 2004 | 8 |
| K031883 | Lyra Nasal Mask | 2003 | 3 |
| K140980 | TI Nasal Mask Class I | 2015 | 2 |
| K034053 | TMS Snapp Soft Nasal Accessory for Positive Pressure, Models TMS-3020, TMS-3030 & TMS-3040 | 2004 | 1 |
| K103434 | 3B Flex-Lite | 2011 | 0 |
| K090804 | Nasal Aire II Pediatric, Model 5 Sizes, Model TBD | 2009 | 0 |
| K080516 | Lamin Air | 2008 | 0 |
| K031896 | Nasal-Air Critical Care | 2004 | 0 |
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.
- K140980TI Nasal MaskRespironics, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K042130 (Aeiomed, Inc., 2004) has gone furthest, with 8 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 Nasal-Aire II™ Interface is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive pressure breathing therapy (i.e. CPAP, BiLevel)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022465 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022465: Modification to Nasal-Aire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022465
Report an extraction error
Are you the manufacturer?
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