510(k) · Cleared
ClearedNasal Aire II Pediatric, Model 5 Sizes, Model TBD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innomed Technologies, Inc./Respcare, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Nov 5, 2009 as substantially equivalent to K060105 (Resmed, Ltd., 2006) and 3 other predicates after a 225-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Nov 5, 2009
- Review
- 225 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K900164 (1990). 22 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK900164 Airway Delivery & Management (Adam) Nasal Ventila.Puritan Bennett Corp. · 1990
- 4 generations backK020641 Spiritus (TM) Respiratory System #SRS 001Worldwide Medical Technologies, LLC · 2002
- 3 generations backK033759 C2 Nasal MaskRespironics, Inc. · 2004
- 2 generations backK042130 Aura Cpap Patient InterfaceAeiomed, Inc. · 2004
- 1 generation backK072993 Reusable Headrest with Nasal SealAeiomed, Inc. · 2008
- This deviceK090804 Nasal Aire II Pediatric, Model 5 Sizes, Model TBDInnomed Technologies, Inc./Respcare, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K900164 | Airway Delivery & Management (Adam) Nasal Ventila. | Puritan Bennett Corp. | 1990 | — |
| −4 | K020641 | Spiritus (TM) Respiratory System #SRS 001 | Worldwide Medical Technologies, LLC | 2002 | — |
| −3 | K033759 | C2 Nasal Mask | Respironics, Inc. | 2004 | — |
| −2 | K042130 | Aura Cpap Patient Interface | Aeiomed, Inc. | 2004 | — |
| −1 | K072993 | Reusable Headrest with Nasal Seal | Aeiomed, Inc. | 2008 | — |
| 0 (this device) | K090804 | Nasal Aire II Pediatric, Model 5 Sizes, Model TBD | Innomed Technologies, Inc./Respcare, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 0 |
| 2006 | 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.
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? (5)
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 |
|---|---|---|---|
| * | K060105 | Vpap Iii ST-a/Kidsta Mask SystemSummary page 1…tilator Classification Name: Non-Continuous (Respirator) Ventilator (21 CFR 868.5905, Product Code BZD) Predicate Devices: 5 10(k) Number: K060105 Manufacturer: ResMed Trade Name: Kidsta Mask System… | 2006 |
| * | K022465 | Modification to Nasal-AireSummary page 1…K060105 Manufacturer: ResMed Trade Name: Kidsta Mask System 5 10(k) Number: K022465 Manufacturer: Innorned Technologies Inc.. Trade Name: Nasal-Aire I… | 2003 |
| * | K002001 | Breeze Sleepgear with DreamsealSummary page 1…Manufacturer: Innorned Technologies Inc.. Trade Name: Nasal-Aire II 5 10(k) Number: K(002001 Manufacturer: Puritan Bennett Corp. Trade Name: Breeze Sleepgear w… | 2000 |
| * | K072993 | Reusable Headrest with Nasal SealSummary page 1…Manufacturer: Puritan Bennett Corp. Trade Name: Breeze Sleepgear with Nasal Pillows 5 10(k) Number: K072993 Manufacturer: AEIOMed, Inc. Trade Name: Reusable Headrest® with… | 2008 |
| * | — | Infant Nasal CPAP Set Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 22 ancestors has a recall.
- 7 other devices also cite its predicate K060105.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments.
The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090804 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090804: Nasal Aire II Pediatric, Model 5 Sizes, Model TBD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090804
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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