510(k) · Cleared
ClearedGE Datex-Ohmeda Heliox Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Sep 20, 2004 as substantially equivalent to K022674 (Bird Products Corp., 2002) and 1 other predicate after a 104-day review. Its family tree reaches back 6 generations to 1991. 15 of the 54 devices in its family, counting itself, have a Class I recall. 30 later devices descend from it.
- Decided
- Sep 20, 2004
- Review
- 104 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K902859 (1991). 23 ancestors in all, the oldest K895541 (1990). 30 later devices descend from it, 2 citing it directly. 15 of the 54 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 4 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 3 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 2 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 1 generation backK022674 Bird Avea VentilatorBird Products Corp. · 2002 · Recalled
- This deviceK041524 GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc. · 2004
- Descendant · cites it directly · 28 of its ownK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- Descendant · 2 generations on · 10 of its ownK131774 Hamilton-G5Hamilton Medical AG · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 9 of its ownK123149 Servo-I Ventilator SystemMaquet Critical Care AB · 2014 · Recalled
- Descendant · 2 generations on · 6 of its ownK083693 PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
- Descendant · 3 generations on · 5 of its ownK103211 Avea VentilatorCare Fusion · 2011 · Recalled (Class I)
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 30 · See all- K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB · 2008 · cites it directly28descendants
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 2 generations on10descendants
- K123149Servo-I Ventilator SystemMaquet Critical Care AB · 2014 · 2 generations on9descendants
- K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009 · 2 generations on6descendants
- K103211Avea VentilatorCare Fusion · 2011 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −5 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −4 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −3 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −2 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −1 | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | 5 |
| 0 (this device) | K041524 | GE Datex-Ohmeda Heliox Delivery System | Datex-Ohmeda, Inc. | 2004 | — |
| +1 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| +2 | K131774 | Hamilton-G5 | Hamilton Medical AG | 2013 | Class I |
| +2 | K123149 | Servo-I Ventilator System | Maquet Critical Care AB | 2014 | 2 |
| +2 | K083693 | PB 840 Ventilator System with Leak Compensation Option, Model 840 | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2009 | — |
| +3 | K103211 | Avea Ventilator | Care Fusion | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 1 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 1 |
| 2013 | 1 | 1 |
| 2014 | 2 | 1 |
| 2015 | 3 | 1 |
| 2016 | 1 | 1 |
| 2017 | 4 | 2 |
| 2019 | 3 | 1 |
| 2020 | 4 | 3 |
| 2021 | 3 | 2 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
15 devices in this family have a Class I recall. 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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 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 |
|---|---|---|---|
| * | K022674 | Bird Avea VentilatorSummary page 3…currently marketed device: Viasys Avea Ventilator - Class 1I - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log number K022674. Puritan Bennett 7200 Series Ventilator -Class II - 21CFR868.5895, which has been the subject of several c… | 2002 |
| * | K922705 | Model 7200AE VentilatorSummary page 3…Puritan Bennett 7200 Series Ventilator -Class II - 21CFR868.5895, which has been the subject of several cleared 510(k)s, most recently with FDA log number K922705 The GE Datex-Ohmeda Aptadr Heliox delivery system is designed to deliver heliox from a source gas cylinder to spontaneously bre… | 1994 |
What descends from it? (30)
See all 302 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (15 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K013642AVEABird Products Corp. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K103211Avea VentilatorCare Fusion · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 3 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 4 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
Nearest 12 of 15 shown.
Nearest 5 of 15; all are on the web page.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 23 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K073179 (Maquet Critical Care AB, 2008) has gone furthest, with 28 descendants of its own.
- 2 other devices also cite its predicate K022674.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The GE Datex-Ohmeda Apta6r Heliox delivery system is designed to deliver heliox from a source gas cylinder to spontaneously breathing patients via a sealed facemask using pressure support. A built-in nebulizer, the Aerogen Aeroneb Pro (K021175) is provided for adding nebulized medication to the delivered heliox. The system is designed for facility use and should only be used under the orders of a clinician.
The Apta6r Heliox Delivery System is not intended as a life support device and is not intended for intubated patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K041524 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041524: GE Datex-Ohmeda Heliox Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041524
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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