510(k) · Cleared
ClearedModel 7200AE Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Puritan Bennett Corp. · CBK Ventilator, Continuous, Facility Use
Cleared on Sep 22, 1994 after an 839-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 of the 32 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it.
- Decided
- Sep 22, 1994
- Review
- 839 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 1 citing it directly. 13 of the 32 devices in this family, counting this one, have a Class I recall.
- This deviceK922705 Model 7200AE VentilatorPuritan Bennett Corp. · 1994
- Descendant · cites it directly · 30 of its ownK041524 GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc. · 2004
- Descendant · 2 generations on · 28 of its ownK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- Descendant · 3 generations on · 10 of its ownK131774 Hamilton-G5Hamilton Medical AG · 2013 · Recalled (Class I)
- Descendant · 3 generations on · 9 of its ownK123149 Servo-I Ventilator SystemMaquet Critical Care AB · 2014 · Recalled
- Descendant · 3 generations on · 6 of its ownK083693 PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 31 · See all- K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc. · 2004 · cites it directly30descendants
- K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB · 2008 · 2 generations on28descendants
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 3 generations on10descendants
- K123149Servo-I Ventilator SystemMaquet Critical Care AB · 2014 · 3 generations on9descendants
- K083693PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922705 | Model 7200AE Ventilator | Puritan Bennett Corp. | 1994 | — |
| +1 | K041524 | GE Datex-Ohmeda Heliox Delivery System | Datex-Ohmeda, Inc. | 2004 | — |
| +2 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| +3 | K131774 | Hamilton-G5 | Hamilton Medical AG | 2013 | Class I |
| +3 | K123149 | Servo-I Ventilator System | Maquet Critical Care AB | 2014 | 2 |
| +3 | K083693 | PB 840 Ventilator System with Leak Compensation Option, Model 840 | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
13 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041524 | GE Datex-Ohmeda Heliox Delivery System | 2004 | 30 |
Has anything in its family been recalled? (13 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.
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K103211Avea VentilatorCare Fusion · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · 6 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K192604Servo-air 4.0 Ventilator SystemMaquet Critica Care AB · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1Maquet Critical Care AB · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 14 Class I recalls
Nearest 12 of 13 shown.
Nearest 5 of 13; all are on the web page.
What does this lineage say?
- Of its descendants, K041524 (Datex-Ohmeda, Inc., 2004) has gone furthest, with 30 descendants of its own.
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) | — |
https://510kreport.com/device/K922705 · printed Nov 5, 2026
Cite this page
510(k) Report. “K922705: Model 7200AE Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K922705
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026