510(k) · Cleared
Recalled · Class I · 2016Modification to Avea Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viasys Respiratory Care, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Jan 25, 2008 as substantially equivalent to K982499 (Novametrix Medical Systems, Inc., 1998) and 2 other predicates after an 87-day review. Its family tree reaches back 3 generations to 1997. 2 of the 15 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 14 times, including 13 Class I recalls.
- Decided
- Jan 25, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 14 (13 Class I)
- Predicates
- 3
Its longest line of descent runs back 3 generations to K962517 (1997). 11 ancestors in all, the oldest K963380 (1997). 3 later devices descend from it, 1 citing it directly. 2 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK962517 Model 7700 Quantum Pressure Support Ventilator PSVHealthdyne Technologies, Inc. · 1997
- 2 generations backK984407 Bipap Harmony S/T, Model 1001445Respironics, Inc. · 1999
- 1 generation backK022132 Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc. · 2002
- This deviceK073069 Modification to Avea VentilatorViasys Respiratory Care, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK093094 Vela VentilatorCardinal Health 207, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK101643 Model LTV 1100 VentilatorCare Fusion · 2011
- Descendant · 3 generations on · 0 of its ownK201082 LTV2 Series VentilatorsVyaire Medical, Inc. · 2021
Class I recalls in this family
- K001646 Puritan-Bennett 840 Ventilator System with…2 generations back · 2000
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K962517 | Model 7700 Quantum Pressure Support Ventilator PSV | Healthdyne Technologies, Inc. | 1997 | — |
| −2 | K984407 | Bipap Harmony S/T, Model 1001445 | Respironics, Inc. | 1999 | — |
| −1 | K022132 | Servo Ventilator System, Model 64 87 800 E407E | Siemens Medical Solutions USA, Inc. | 2002 | — |
| 0 (this device) | K073069 | Modification to Avea Ventilator | Viasys Respiratory Care, Inc. | 2008 | — |
| +1 | K093094 | Vela Ventilator | Cardinal Health 207, Inc. | 2010 | — |
| +2 | K101643 | Model LTV 1100 Ventilator | Care Fusion | 2011 | — |
| +3 | K201082 | LTV2 Series Ventilators | Vyaire Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2021 | 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.
2 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? (3)
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 |
|---|---|---|---|
| * | K982499 | Cosmo Plus with Nico, Model 8200Summary page 1…Device Class: Class I1 Classification Anesthesiology Panel: Predicate Device: The predicate devices are: • Respironics NICO K982499 * Maquet Servo-I K022132 * Cosmo Plus 8000 K963380 Device The… | 1998 |
| * | K022132 | Servo Ventilator System, Model 64 87 800 E407ESummary page 1…Anesthesiology Panel: Predicate Device: The predicate devices are: • Respironics NICO K982499 * Maquet Servo-I K022132 * Cosmo Plus 8000 K963380 Device The AVEA is a servo-controlled, software-driven ventila… | 2002 |
| * | K963380 | CO 2 Smo PlusSummary page 1…edicate devices are: • Respironics NICO K982499 * Maquet Servo-I K022132 * Cosmo Plus 8000 K963380 Device The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic Description: range of… | 1997 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093094 | Vela Ventilator | 2010 | 2 |
Has anything in its family been recalled? (2 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… |
The 5 latest of 14 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
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K093094 (Cardinal Health 207, Inc., 2010) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K982499.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073069 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073069: Modification to 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/K073069
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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