510(k) · Cleared
Recalled · 2007Avea 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 Sep 20, 2006 as substantially equivalent to K031745 (Sensor Medics Corp., 2004) and 1 other predicate after a 58-day review. Its family tree reaches back 3 generations to 1991. 10 of the 35 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it. It has been recalled 5 times.
- Decided
- Sep 20, 2006
- Review
- 58 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 3 generations to K902859 (1991). 13 ancestors in all, the oldest K833982 (1984). 21 later devices descend from it, 3 citing it directly. 10 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 2 generations backK961687 EVITA 4Drager, Inc. · 1996
- 1 generation backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- This deviceK062093 Avea VentilatorViasys Respiratory Care, Inc. · 2006
- Descendant · cites it directly · 16 of its ownK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008 · Recalled (Class I)
- Descendant · 2 generations on · 14 of its ownK102775 Hamilton-C2Hamilton Medical AG · 2011
- Descendant · 3 generations on · 13 of its ownK112006 Hamilton-TC1Hamilton Medical AG · 2012
- Descendant · 4 generations on · 11 of its ownK120670 Hamilton-T1Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 8 of its ownK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · cites it directly16descendants
- K102775Hamilton-C2Hamilton Medical AG · 2011 · 2 generations on14descendants
- K112006Hamilton-TC1Hamilton Medical AG · 2012 · 3 generations on13descendants
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 4 generations on11descendants
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −2 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −1 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| 0 (this device) | K062093 | Avea Ventilator | Viasys Respiratory Care, Inc. | 2006 | — |
| +1 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
| +2 | K102775 | Hamilton-C2 | Hamilton Medical AG | 2011 | — |
| +3 | K112006 | Hamilton-TC1 | Hamilton Medical AG | 2012 | — |
| +4 | K120670 | Hamilton-T1 | Hamilton Medical AG | 2012 | Class I |
| +3 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 1 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 6 | 2 |
| 2013 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 2 | 1 |
| 2019 | 1 | 1 |
| 2020 | 1 | 1 |
| 2021 | 1 | 1 |
| 2024 | 1 | 0 |
| 2026 | 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.
10 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 |
|---|---|---|---|
| * | K031745 | Infant Flow Plus Infant Cpap System with Sipap FunctionSummary page 1…Anesthesiology Panel: Predicate Device: The predicate devices are: 510K Product Manufacturer 1 K031745 Infant Flow Plus Infant CPAP VIASYS Respiratory System Care Inc… | 2004 |
| * | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Summary page 1…SYS Respiratory System Care Inc (Trade Name: SIPAP System) 2 K970460 840 Ventilator with Neo Mode Tyco Puritan Bennett Option Device The AVEA is a s… | 1998 |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 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.
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 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
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 5 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 5 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 3 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K081521 (Hamilton Medical AG, 2008) has gone furthest, with 16 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) | — |
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/K062093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062093: Avea Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062093
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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