510(k) · Cleared
ClearedAura Cpap System
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 Mar 9, 2005 as substantially equivalent to K030985 (Vital Signs, Inc., 2003) and 1 other predicate after a 135-day review. Its family tree reaches back 6 generations to 1990. 6 later devices descend from it.
- Decided
- Mar 9, 2005
- Review
- 135 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K903764 (1990). 15 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- 5 generations backK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
- 4 generations backK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
- 3 generations backK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
- 2 generations backK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
- 1 generation backK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
- This deviceK042945 Aura Cpap SystemAeiomed, Inc. · 2005
- 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 · 3 generations on · 0 of its ownK180388 Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK150365 Cloud9 SystemInsleep Technologies, LLC · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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
- K180388Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018 · 3 generations on0descendants
- K150365Cloud9 SystemInsleep Technologies, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903764 | Companion 318 Nasal Cpap System | Puritan Bennett Corp. | 1990 | — |
| −5 | K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | Puritan Bennett Corp. | 1996 | — |
| −4 | K980365 | Goodknight 418 Cpap System | Nellcor Puritan Bennett, Inc. | 1998 | — |
| −3 | K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | 1999 | — |
| −2 | K993584 | Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 | Nellcor Puritan Bennett France Dvpt. | 2000 | — |
| −1 | K030985 | Breas PV 10I Cpap System, Model PV 10I | Vital Signs, Inc. | 2003 | — |
| 0 (this device) | K042945 | Aura Cpap System | Aeiomed, Inc. | 2005 | — |
| +1 | K100121 | Model 300157 Cpap System | Aeiomed, Inc. | 2010 | — |
| +2 | K132127 | Transcend Auto | Somnetics International, Inc. | 2013 | — |
| +2 | K121374 | ZI Blower | Deshum Medical | 2013 | — |
| +3 | K180388 | Transcend 365 miniCPAP System | Somnetics International, Inc. | 2018 | — |
| +2 | K150365 | Cloud9 System | Insleep Technologies, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K030985 | Breas PV 10I Cpap System, Model PV 10ISummary page 1…n Name: CPAP Device Classification Name: 21 CER 868.5905, Non-Continuous (Respirator) Ventilator Predicate Devices: 5 10(k) Number: K(030985 Manufacture: Vital Signs, Inc. Trade Name: BREAS PV IO… | 2003 |
| * | K010263 | Remstar Plus Cpap SystemSummary page 1…Manufacture: Vital Signs, Inc. Trade Name: BREAS PV IO CPAP System 5 10(k) Number: K010263 Manufacture: Respironics, Inc. Trade Name: REMstar Plu… | 2001 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100121 | Model 300157 Cpap System | 2010 | 5 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K100121 (Aeiomed, Inc., 2010) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K030985.
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 aura CPAP System provides continuous positive airway pressure (CPAP) to support
treatment of adults (over 30kg) with Obstructive Sleep Apnea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042945 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042945: Aura Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042945
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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