510(k) · Cleared
Recalled · 2007Bird Avea Ventilator
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 Nov 6, 2002 as substantially equivalent to K013642 (Bird Products Corp., 2002) after an 86-day review. Its family tree reaches back 5 generations to 1991. 26 of the 80 devices in its family, counting itself, have a Class I recall. 58 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 6, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902859 (1991). 21 ancestors in all, the oldest K895541 (1990). 58 later devices descend from it, 3 citing it directly. 26 of the 80 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 4 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 3 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 2 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 1 generation backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- This deviceK022674 Bird Avea VentilatorBird Products Corp. · 2002
- Descendant · cites it directly · 30 of its ownK041524 GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc. · 2004
- Descendant · cites it directly · 29 of its ownK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- 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 · 12 of its ownK070594 Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 10 of its ownK133868 Astral VentilatorResmed, Ltd. · 2014 · Recalled
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 58 · See all- K041524GE Datex-Ohmeda Heliox Delivery SystemDatex-Ohmeda, Inc. · 2004 · cites it directly30descendants
- K060647LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006 · cites it directly29descendants
- K073179Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585Maquet Critical Care AB · 2008 · cites it directly28descendants
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 2 generations on12descendants
- K133868Astral VentilatorResmed, Ltd. · 2014 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −4 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −3 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −2 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −1 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| 0 (this device) | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | — |
| +1 | K041524 | GE Datex-Ohmeda Heliox Delivery System | Datex-Ohmeda, Inc. | 2004 | — |
| +1 | K060647 | LTV 1200 Ventilator | Pulmonetic Systems, Inc. | 2006 | — |
| +1 | K073179 | Servo-I Ventilator System Model 64 87 800 E4073, Heliox Option, Model 6675585 | Maquet Critical Care AB | 2008 | — |
| +2 | K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 | Pulmonetic Systems, Inc. | 2007 | Class I |
| +2 | K133868 | Astral Ventilator | Resmed, Ltd. | 2014 | 2 |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 0 |
| 2009 | 4 | 1 |
| 2010 | 1 | 0 |
| 2011 | 4 | 2 |
| 2012 | 2 | 1 |
| 2013 | 2 | 1 |
| 2014 | 3 | 1 |
| 2015 | 4 | 1 |
| 2016 | 3 | 2 |
| 2017 | 6 | 4 |
| 2018 | 1 | 1 |
| 2019 | 5 | 3 |
| 2020 | 4 | 3 |
| 2021 | 5 | 3 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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.
26 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? (4)
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 |
|---|---|---|---|
| * | K013642 | AVEASummary page 2…r the direction of a physician should only operate it. The modified AVEA Ventilator is the same device as the AVEA Ventilator, which was cleared for market under 510(k) K013642, except for the addition of a heliox connector and associated conforming labeling changes. The modified AVEA Ventilator have the… | 2002 |
| * | — | DATEX-OHMEDA AESTIVA/5 with DATEX-OHMEDA 7100 Ventilator Anesthesia System Named without a submission number | |
| * | — | OHMEDA EXCEL 3000 Anesthesia Gas System Named without a submission number | |
| * | — | HOPE Nebulizer Named without a submission number |
What descends from it? (58)
See all 583 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (26 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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. |
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 · Direct predicate · ◆ on the line of descent in FIG. 113 Class I recalls
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 2 generations back · ◆ 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
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 2 generations on · ◆ in the 2013 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
- 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
- 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
- K152068Astral 100/150Resmed, Ltd. · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
Nearest 12 of 26 shown.
Nearest 5 of 26; 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 1.9 years on median.
- 7 of the 21 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K041524 (Datex-Ohmeda, Inc., 2004) has gone furthest, with 30 descendants of its own.
- 4 other devices also cite its predicate K013642.
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 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. The AVEA is indicated for the delivery of air, oxygen or a helium-oxygen combination (Heliox).
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/K022674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022674: Bird 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/K022674
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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