510(k) · Cleared
ClearedZI Blower
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deshum Medical · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Feb 22, 2013 as substantially equivalent to K100121 (Aeiomed, Inc., 2010) and 2 other predicates after a 291-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Feb 22, 2013
- Review
- 291 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K903764 (1990). 31 ancestors in all, the oldest K900164 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK903764 Companion 318 Nasal Cpap SystemPuritan Bennett Corp. · 1990
- 7 generations backK960518 The Puritan-Bennett 318 Plus Nasal Cpap SystemPuritan Bennett Corp. · 1996
- 6 generations backK980365 Goodknight 418 Cpap SystemNellcor Puritan Bennett, Inc. · 1998
- 5 generations backK991150 Nellcor Puritan Bennett, Goodknight 418GNellcor Puritan Bennett France Dvpt. · 1999
- 4 generations backK993584 Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2Nellcor Puritan Bennett France Dvpt. · 2000
- 3 generations backK030985 Breas PV 10I Cpap System, Model PV 10IVital Signs, Inc. · 2003
- 2 generations backK042945 Aura Cpap SystemAeiomed, Inc. · 2005
- 1 generation backK100121 Model 300157 Cpap SystemAeiomed, Inc. · 2010
- This deviceK121374 ZI BlowerDeshum Medical · 2013
- Descendant · cites it directly · 0 of its ownK140929 Z1 Cpap SystemHuman Design Medical, LLC · 2014
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −8 | K903764 | Companion 318 Nasal Cpap System | Puritan Bennett Corp. | 1990 | — |
| −7 | K960518 | The Puritan-Bennett 318 Plus Nasal Cpap System | Puritan Bennett Corp. | 1996 | — |
| −6 | K980365 | Goodknight 418 Cpap System | Nellcor Puritan Bennett, Inc. | 1998 | — |
| −5 | K991150 | Nellcor Puritan Bennett, Goodknight 418G | Nellcor Puritan Bennett France Dvpt. | 1999 | — |
| −4 | K993584 | Mallinckrodt, Goodknight 418A, Goodknight 418P, Silverlining 2 | Nellcor Puritan Bennett France Dvpt. | 2000 | — |
| −3 | K030985 | Breas PV 10I Cpap System, Model PV 10I | Vital Signs, Inc. | 2003 | — |
| −2 | K042945 | Aura Cpap System | Aeiomed, Inc. | 2005 | — |
| −1 | K100121 | Model 300157 Cpap System | Aeiomed, Inc. | 2010 | — |
| 0 (this device) | K121374 | ZI Blower | Deshum Medical | 2013 | — |
| +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 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K100121 | Model 300157 Cpap SystemSummary page 1…tinuous (Respirator) Ventilator, 21 CFR § 868.5905 Device Class: Class II Predicate Devices: 5 10(k) Number: K100121 Manufacturer: AETOMed, Inc. Product Name: Model 300157… | 2010 |
| * | K052597 | Breathex Omega Cpap Device, Model 322Summary page 1…Manufacturer: AETOMed, Inc. Product Name: Model 300157 CPAP System 5 10(k) Number: K052597 Manufacturer: Hoffman Laboratories, LLC Product Name: B… | 2005 |
| * | K013843 | Autoset Spirit Cpap SystemSummary page 1…Product Name: Breathex Omega CPAP Device, Model 322 5 10(k) Number: K013843 Manufacturer: Resmed Corp. Product Name: Autoset Spirit… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140929 | Z1 Cpap System | 2014 | 0 |
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 23 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 31 ancestors has a recall of any class.
- Of its descendants, K140929 (Human Design Medical, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K100121.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 ZI blower is a single patient reusable device that 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/K121374 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121374: ZI Blower.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121374
Report an extraction error
Are you the manufacturer?
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