510(k) · Cleared
ClearedAura Cpap Patient Interface
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aeiomed, Inc. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 8, 2004 as substantially equivalent to K022465 (Innomed Technologies, 2003) and 1 other predicate after a 33-day review. Its family tree reaches back 3 generations to 1990. 8 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 33 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K900164 (1990). 4 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK900164 Airway Delivery & Management (Adam) Nasal Ventila.Puritan Bennett Corp. · 1990
- 2 generations backK020641 Spiritus (TM) Respiratory System #SRS 001Worldwide Medical Technologies, LLC · 2002
- 1 generation backK033759 C2 Nasal MaskRespironics, Inc. · 2004
- This deviceK042130 Aura Cpap Patient InterfaceAeiomed, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK132127 Transcend AutoSomnetics International, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK121374 ZI BlowerDeshum Medical · 2013
- Descendant · cites it directly · 1 of its ownK072993 Reusable Headrest with Nasal SealAeiomed, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK180388 Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K100121Model 300157 Cpap SystemAeiomed, Inc. · 2010 · cites it directly5descendants
- K132127Transcend AutoSomnetics International, Inc. · 2013 · 2 generations on1descendant
- K121374ZI BlowerDeshum Medical · 2013 · 2 generations on1descendant
- K072993Reusable Headrest with Nasal SealAeiomed, Inc. · 2008 · cites it directly1descendant
- K180388Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K900164 | Airway Delivery & Management (Adam) Nasal Ventila. | Puritan Bennett Corp. | 1990 | — |
| −2 | K020641 | Spiritus (TM) Respiratory System #SRS 001 | Worldwide Medical Technologies, LLC | 2002 | — |
| −1 | K033759 | C2 Nasal Mask | Respironics, Inc. | 2004 | — |
| 0 (this device) | K042130 | Aura Cpap Patient Interface | Aeiomed, Inc. | 2004 | — |
| +1 | K100121 | Model 300157 Cpap System | Aeiomed, Inc. | 2010 | — |
| +2 | K132127 | Transcend Auto | Somnetics International, Inc. | 2013 | — |
| +2 | K121374 | ZI Blower | Deshum Medical | 2013 | — |
| +1 | K072993 | Reusable Headrest with Nasal Seal | Aeiomed, Inc. | 2008 | — |
| +3 | K180388 | Transcend 365 miniCPAP System | Somnetics International, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K022465 | Modification to Nasal-AireSummary page 1…ry: Nasal CPAP Mask Classification Name: 21 CFR 868.5905, Non-Continuous (Respirator) Ventilator Predicate Devices: 510(k) Number: K022465 Manufacture: Innorned Technologies Trade Name: Nas… | 2003 |
| * | K033759 | C2 Nasal MaskSummary page 1…Manufacture: Innorned Technologies Trade Name: Nasal-Aire IlTM 5 10(k) Number: K(033759 Manufacture: Respironics, Inc. Trade Name: Comfort… | 2004 |
What descends from it? (8)
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?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K100121 (Aeiomed, Inc., 2010) has gone furthest, with 5 descendants of its own.
- 7 other devices also cite its predicate K022465.
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 AuraTM CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042130: Aura Cpap Patient Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042130
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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