510(k) · Cleared
Recalled · Class I · 2016AVEA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bird Products Corp. · CBK Ventilator, Continuous, Facility Use
Cleared on May 22, 2002 as substantially equivalent to K970460 (Puritan Bennett Corp., 1998) and 6 other predicates after a 198-day review. Its family tree reaches back 4 generations to 1991. 42 of the 154 devices in its family, counting itself, have a Class I recall. 133 later devices descend from it. It has been recalled 19 times, including 13 Class I recalls.
- Decided
- May 22, 2002
- Review
- 198 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 19 (13 Class I)
- Predicates
- 7
Its longest line of descent runs back 4 generations to K902859 (1991). 20 ancestors in all, the oldest K895541 (1990). 133 later devices descend from it, 5 citing it directly. 42 of the 154 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 3 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 2 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 1 generation backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- This deviceK013642 AVEABird Products Corp. · 2002
- Descendant · cites it directly · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 2 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- Descendant · 3 generations on · 86 of its ownK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- Descendant · 4 generations on · 61 of its ownK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
Showing 5 of 133 descendants. See all descendants
Descendants cleared per year
2002high 12 (2011) · low 0 (2003)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 133 · See all- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · cites it directly114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 2 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 2 generations on87descendants
- K061627Modification to I Vent 201Versamed Medical Systems, Inc. · 2006 · 3 generations on86descendants
- K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007 · 4 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −3 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −2 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −1 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| 0 (this device) | K013642 | AVEA | Bird Products Corp. | 2002 | — |
| +1 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +2 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +2 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +3 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +4 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 1 |
| 2008 | 8 | 1 |
| 2009 | 5 | 1 |
| 2010 | 5 | 1 |
| 2011 | 12 | 7 |
| 2012 | 11 | 4 |
| 2013 | 10 | 4 |
| 2014 | 6 | 1 |
| 2015 | 8 | 1 |
| 2016 | 8 | 3 |
| 2017 | 11 | 5 |
| 2018 | 3 | 1 |
| 2019 | 7 | 3 |
| 2020 | 4 | 3 |
| 2021 | 7 | 3 |
| 2022 | 1 | 0 |
| 2023 | 2 | 1 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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.
42 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? (7)
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 |
|---|---|---|---|
| * | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Summary page 2…predicate device. The predicate devices used for substantial equivalence determination are as follows: 510(k) Number Trade or proprietary or model name Manufacturer 1 K970460 840 Puritan Bennett 2 K961687 EVITA 4 Drager 3 K902859 SERVO VENTILATOR 300 SIEMENS 4 K992788 Bear Cub 750 PSV Bear Medical Sy… | 1998 |
| * | K961687 | EVITA 4Summary page 2…e devices used for substantial equivalence determination are as follows: 510(k) Number Trade or proprietary or model name Manufacturer 1 K970460 840 Puritan Bennett 2 K961687 EVITA 4 Drager 3 K902859 SERVO VENTILATOR 300 SIEMENS 4 K992788 Bear Cub 750 PSV Bear Medical Systems 5 K983981 Bear 1000es Be… | 1996 |
| * | K902859 | Servo Ventilator 300Summary page 2…tial equivalence determination are as follows: 510(k) Number Trade or proprietary or model name Manufacturer 1 K970460 840 Puritan Bennett 2 K961687 EVITA 4 Drager 3 K902859 SERVO VENTILATOR 300 SIEMENS 4 K992788 Bear Cub 750 PSV Bear Medical Systems 5 K983981 Bear 1000es Bear Medical Systems 6 K993… | 1991 |
| * | K992788 | Bear Cub 750 PSVSummary page 2…llows: 510(k) Number Trade or proprietary or model name Manufacturer 1 K970460 840 Puritan Bennett 2 K961687 EVITA 4 Drager 3 K902859 SERVO VENTILATOR 300 SIEMENS 4 K992788 Bear Cub 750 PSV Bear Medical Systems 5 K983981 Bear 1000es Bear Medical Systems 6 K993449 VIP Gold/Sterling Bird Products Corp… | 1999 |
| * | K983981 | Bear 1000, Veolar W Leonardo Graphics, Bicore CP-2000, Bicore CP-100, HI-LO Jet ET TubeSummary page 2…el name Manufacturer 1 K970460 840 Puritan Bennett 2 K961687 EVITA 4 Drager 3 K902859 SERVO VENTILATOR 300 SIEMENS 4 K992788 Bear Cub 750 PSV Bear Medical Systems 5 K983981 Bear 1000es Bear Medical Systems 6 K993449 VIP Gold/Sterling Bird Products Corporation 7 KO00706 DATEX-OHMEDA AESTIVA/S with 710… | 1998 |
| * | K993449 | Bird V.I.P. Gold/SterlingSummary page 2…Bennett 2 K961687 EVITA 4 Drager 3 K902859 SERVO VENTILATOR 300 SIEMENS 4 K992788 Bear Cub 750 PSV Bear Medical Systems 5 K983981 Bear 1000es Bear Medical Systems 6 K993449 VIP Gold/Sterling Bird Products Corporation 7 KO00706 DATEX-OHMEDA AESTIVA/S with 7100 DATEX: OHMEDA Ventilator Anesthesia Syste… | 1999 |
| * | K000706 | Datex-Ohmeda Aestiva/5 with 7100 Ventilator | 2000 |
What descends from it? (133)
See all 1335 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (42 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… |
| 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… |
| Dec 17, 2007 | Not classified | Z-0982-2008 | Component design/selection | Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition. |
| Dec 17, 2007 | Not classified | Z-0983-2008 | Component design/selection | Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition. |
| Dec 17, 2007 | Not classified | Z-0984-2008 | Component design/selection | Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition. |
| Dec 17, 2007 | Not classified | Z-0986-2008 | Component design/selection | Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition. |
| Dec 17, 2007 | Not classified | Z-0985-2008 | Component design/selection | Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition. |
The 5 latest of 19 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.
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 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
Nearest 12 of 41 shown.
Nearest 5 of 41; all are on the web page.
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 6 of the 20 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K032451 (Bird Products Corp., 2004) has gone furthest, with 114 descendants of its own.
- 6 other devices also cite its predicate K970460.
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
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 adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.
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/K013642 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013642: AVEA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013642
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026