510(k) · Cleared
ClearedZ1 Cpap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Human Design Medical, LLC · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Oct 17, 2014 as substantially equivalent to K121374 (Deshum Medical, 2013) and 2 other predicates after a 191-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Oct 17, 2014
- Review
- 191 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K903764 (1990). 33 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- 5 generations between
- 3 generations backK042945 Aura Cpap SystemAeiomed, Inc. · 2005
- 2 generations backK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
- 1 generation backK121374 ZI BlowerDeshum Medical · 2013
- This deviceK140929 Z1 Cpap SystemHuman Design Medical, LLC · 2014
Show all 9 generations
- Root · 9 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- 8 generations backK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
- 7 generations backK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
- 6 generations backK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
- 5 generations backK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
- 4 generations backK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
- 3 generations backK042945 Aura Cpap SystemAeiomed, Inc. · 2005
- 2 generations backK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
- 1 generation backK121374 ZI BlowerDeshum Medical · 2013
- This deviceK140929 Z1 Cpap SystemHuman Design Medical, LLC · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K903764 | Companion 318 Nasal Cpap System | Puritan Bennett Corp. | 1990 | — |
| −8 | K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | Puritan Bennett Corp. | 1996 | — |
| −7 | K980365 | Goodknight 418 Cpap System | Nellcor Puritan Bennett, Inc. | 1998 | — |
| −6 | K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | 1999 | — |
| −5 | K993584 | Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 | Nellcor Puritan Bennett France Dvpt. | 2000 | — |
| −4 | K030985 | Breas PV 10I Cpap System, Model PV 10I | Vital Signs, Inc. | 2003 | — |
| −3 | K042945 | Aura Cpap System | Aeiomed, Inc. | 2005 | — |
| −2 | K100121 | Model 300157 Cpap System | Aeiomed, Inc. | 2010 | — |
| −1 | K121374 | ZI Blower | Deshum Medical | 2013 | — |
| 0 (this device) | 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 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K121374 | ZI BlowerSummary page 4…us (Respirator) Ventilator, 21 CFR § 868.5905 Device Class: Class II Predicate Devices: 510(k) Number: K121374 Manufacturer: Human Design Medical, LLC Product Name:… | 2013 |
| * | K063476 | Breas Isleep 20ISummary page 4…Manufacturer: Human Design Medical, LLC Product Name: Z1 Blower 510(k) Number: K063476 Manufacturer: Breas Medical AB Product Name: iSleep… | 2007 |
| * | K100121 | Model 300157 Cpap SystemSummary page 4…Manufacturer: Breas Medical AB Product Name: iSleep 20i 510(k) Number: K100121 Manufacturer: AeioMed, Inc. Product Name: Model 300… | 2010 |
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 24 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 33 ancestors has a recall of any class.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Z1 CPAP System is a single patient reusable device that provides continuous positive airway pressure (CPAP) to support treatment of adults weighing over 66 lbs (30 kg) with obstructive sleep apnea.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140929 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140929: Z1 Cpap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140929
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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