510(k) · Cleared
Recalled · Class I · 2016Avea Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Care Fusion · CBK Ventilator, Continuous, Facility Use
Cleared on May 12, 2011 as substantially equivalent to K083693 (Covidien, Formerly Nellcor Puritan Bennett, Inc., 2009) and 1 other predicate after a 192-day review. Its family tree reaches back 12 generations to 1991. 11 of the 79 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 15 times, including 14 Class I recalls.
- Decided
- May 12, 2011
- Review
- 192 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 15 (14 Class I)
- Predicates
- 2
Its longest line of descent runs back 12 generations to K902859 (1991). 73 ancestors in all, the oldest K883038 (1988). 5 later devices descend from it, 2 citing it directly. 11 of the 79 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations between
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- 1 generation backK083693 PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
- This deviceK103211 Avea VentilatorCare Fusion · 2011
- Descendant · cites it directly · 2 of its ownK131252 Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK162738 Puritan Bennett 980 Ventilator SystemCovidien · 2017 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK162832 731 Series VentilatorsZOLL Medical Corporation · 2017 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK233486 731 Series VentilatorZOLL Medical Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK193056 Puritan Bennett 980 Series Ventilator SystemCovidien, LLC · 2020 · Recalled (Class I)
Show all 12 generations
- Root · 12 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 10 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 9 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 8 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 7 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 6 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 5 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 4 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 2 generations backK073179 Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option…Maquet Critical Care AB · 2008
- 1 generation backK083693 PB 840 Ventilator System with Leak Compensation Option, Model 840Covidien, Formerly Nellcor Puritan Bennett, Inc. · 2009
- This deviceK103211 Avea VentilatorCare Fusion · 2011
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · cites it directly2descendants
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · 2 generations on1descendant
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · cites it directly1descendant
- K233486731 Series VentilatorZOLL Medical Corporation · 2024 · 2 generations on0descendants
- K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −11 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −10 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −9 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −8 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −7 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −6 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −5 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −4 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −2 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| −1 | K083693 | PB 840 Ventilator System with Leak Compensation Option, Model 840 | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2009 | — |
| 0 (this device) | K103211 | Avea Ventilator | Care Fusion | 2011 | — |
| +1 | K131252 | Puritan Bennett 980 Series Ventilator System | Covidien | 2014 | Class I |
| +2 | K162738 | Puritan Bennett 980 Ventilator System | Covidien | 2017 | Class I |
| +1 | K162832 | 731 Series Ventilators | ZOLL Medical Corporation | 2017 | Class I |
| +2 | K233486 | 731 Series Ventilator | ZOLL Medical Corporation | 2024 | — |
| +3 | K193056 | Puritan Bennett 980 Series Ventilator System | Covidien, LLC | 2020 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 9 | 3 |
| 1999 | 5 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
| 2017 | 2 | 2 |
| 2020 | 1 | 1 |
| 2024 | 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.
11 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 |
|---|---|---|---|
| * | K083693 | PB 840 Ventilator System with Leak Compensation Option, Model 840Summary page 1…0001 Registration Number Device Class: Class 11 Classification Anesthesiology Panel: Predicate Device: The predicate devices are: 1. K083693: 840 Ventilator (Covidien) 2. K974176: Baby log 8000 (Drager Inc.) Device The AVEA is a se… | 2009 |
| * | K974176 | Babylog 8000 PlusSummary page 1…assification Anesthesiology Panel: Predicate Device: The predicate devices are: 1. K083693: 840 Ventilator (Covidien) 2. K974176: Baby log 8000 (Drager Inc.) Device The AVEA is a servo-controlled, software-driven ventilator. It has a Descr… | 1998 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 17, 2016 | Class I | Z-1888-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1895-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1896-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1899-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1892-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1897-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1898-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1894-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1889-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1891-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1890-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| May 17, 2016 | Class I | Z-1893-2016 | Under Investigation by firm | CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface… |
| Apr 3, 2015 | Class I | Z-1609-2015 | Process control | A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to… |
| Sep 5, 2013 | Class I | Z-2273-2013 | Component design/selection | CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a… |
| Sep 8, 2011 | Not classified | Z-0510-2012 | Nonconforming Material/Component | The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating… |
The 5 latest of 15 recalls; the web page lists all.
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.
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 4 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · Cites it directly · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 117 Class I recalls
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 20 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 21 of the 73 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K131252 (Covidien, 2014) has gone furthest, with 2 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. 2011, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2007high 18 (2008) · low 0 (2022)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
2007high 439 (2014) · low 115 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
2007high 23 (2008) · low 0 (2025)2026
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
2007high 24,928 (2023) · low 1,531 (2007)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 AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103211: Avea Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103211
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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