510(k) · Cleared
ClearedModel 300157 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 Jul 13, 2010 as substantially equivalent to K042945 (Aeiomed, Inc., 2005) and 2 other predicates after a 179-day review. Its family tree reaches back 7 generations to 1990. 5 later devices descend from it.
- Decided
- Jul 13, 2010
- Review
- 179 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K903764 (1990). 28 ancestors in all, the oldest K900164 (1990). 5 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- 6 generations backK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
- 5 generations backK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
- 4 generations backK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
- 3 generations backK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
- 2 generations backK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
- 1 generation backK042945 Aura Cpap SystemAeiomed, Inc. · 2005
- This deviceK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK132127 Transcend AutoSomnetics International, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK121374 ZI BlowerDeshum Medical · 2013
- Descendant · 2 generations on · 0 of its ownK180388 Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK150365 Cloud9 SystemInsleep Technologies, LLC · 2015
- Descendant · cites it directly · 0 of its ownK140929 Z1 Cpap SystemHuman Design Medical, LLC · 2014
Most influential descendants
Showing 5 of 5 · See all- K132127Transcend AutoSomnetics International, Inc. · 2013 · cites it directly1descendant
- K121374ZI BlowerDeshum Medical · 2013 · cites it directly1descendant
- K180388Transcend 365 miniCPAP SystemSomnetics International, Inc. · 2018 · 2 generations on0descendants
- K150365Cloud9 SystemInsleep Technologies, LLC · 2015 · cites it directly0descendants
- K140929Z1 Cpap SystemHuman Design Medical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K903764 | Companion 318 Nasal Cpap System | Puritan Bennett Corp. | 1990 | — |
| −6 | K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | Puritan Bennett Corp. | 1996 | — |
| −5 | K980365 | Goodknight 418 Cpap System | Nellcor Puritan Bennett, Inc. | 1998 | — |
| −4 | K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | 1999 | — |
| −3 | K993584 | Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 | Nellcor Puritan Bennett France Dvpt. | 2000 | — |
| −2 | K030985 | Breas PV 10I Cpap System, Model PV 10I | Vital Signs, Inc. | 2003 | — |
| −1 | K042945 | Aura Cpap System | Aeiomed, Inc. | 2005 | — |
| 0 (this device) | K100121 | Model 300157 Cpap System | Aeiomed, Inc. | 2010 | — |
| +1 | K132127 | Transcend Auto | Somnetics International, Inc. | 2013 | — |
| +1 | K121374 | ZI Blower | Deshum Medical | 2013 | — |
| +2 | K180388 | Transcend 365 miniCPAP System | Somnetics International, Inc. | 2018 | — |
| +1 | K150365 | Cloud9 System | Insleep Technologies, LLC | 2015 | — |
| +1 | K140929 | Z1 Cpap System | Human Design Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K042945 | Aura Cpap SystemSummary page 1…mon Name: CPAP Device Classification Name: 21 CFR 868.5905, Non-Continuous (Respirator) Ventilator Predicate Devices: 5 I 0(k) Number: K042945 Manufacture: AEIOMed, Inc Trade Name: Aura… | 2005 |
| * | K042130 | Aura Cpap Patient InterfaceSummary page 1…K042945 Manufacture: AEIOMed, Inc Trade Name: Aura 5 10O(k) Number: K042130 Manufacture: AEIOMed, Inc Trade Name: Aura Interface === Pa… | 2004 |
| * | K052597 | Breathex Omega Cpap Device, Model 322Summary page 2…Manufacture: AEIOMed, Inc Trade Name: Aura Interface 5 10(k) Number: K052597 Manufacture: Hoffman Trade Name: BreatheX 1.0 Descriptio… | 2005 |
What descends from it? (5)
4 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 20 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 28 ancestors has a recall of any class.
- Of its descendants, K132127 (Somnetics International, Inc., 2013) has gone furthest, with 1 descendant 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. 2010, 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 Model 300157 CPAP System is a single patient reusable device. The Model 300157 CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30 kg) with Obstructive Sleep Apnea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100121: Model 300157 Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100121
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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