510(k) · Cleared
ClearedAvea Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinal Health 207, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Aug 13, 2008 as substantially equivalent to K013642 (Bird Products Corp., 2002) and 1 other predicate after a 44-day review. Its family tree reaches back 5 generations to 1991. 8 of the 36 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Aug 13, 2008
- Review
- 44 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K902859 (1991). 22 ancestors in all, the oldest K895541 (1990). 13 later devices descend from it, 2 citing it directly. 8 of the 36 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 deviceK081837 Avea VentilatorCardinal Health 207, Inc. · 2008
- Descendant · cites it directly · 11 of its ownK092847 840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK151252 Puritan Bennett 840 Series Ventilator SystemCovidien LP · 2016
- Descendant · 3 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · 4 generations on · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK131252 Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · Recalled (Class I)
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K092847840 Ventilator System with Expanded Neomode OptionCovidien, Formerly Nellcor Puritan Bennett, Inc. · 2010 · cites it directly11descendants
- K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP · 2016 · 2 generations on7descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on2descendants
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 2 generations on2descendants
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) | K081837 | Avea Ventilator | Cardinal Health 207, Inc. | 2008 | — |
| +1 | K092847 | 840 Ventilator System with Expanded Neomode Option | Covidien, Formerly Nellcor Puritan Bennett, Inc. | 2010 | — |
| +2 | K151252 | Puritan Bennett 840 Series Ventilator System | Covidien LP | 2016 | — |
| +3 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +4 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +2 | K131252 | Puritan Bennett 980 Series Ventilator System | Covidien | 2014 | Class I |
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 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 1 | 1 |
| 2019 | 2 | 2 |
| 2020 | 1 | 1 |
| 2021 | 1 | 1 |
| 2024 | 2 | 0 |
| 2025 | 3 | 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.
8 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 |
|---|---|---|---|
| * | K013642 | AVEASummary page 1…* Existing reusable filter assembly (Which is part of the AVEA Ventilator, cleared under K013642) - Intersurgical: Clear Guard II- K990949 Device Description: T… | 2002 |
| * | K990949 | Clear-Guard II, Clear-Therm Hmef, Clear-Therm Hmef W/ Flextube, Clear Guard 11 W/ Gas…Summary page 1…of the AVEA Ventilator, cleared under K013642) - Intersurgical: Clear Guard II- K990949 Device Description: The AVEA Ventilator is a fourth generation servo-controlled, software-… | 1999 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (8 Class I)
No FDA recall names this device.
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
- K131252Puritan Bennett 980 Series Ventilator SystemCovidien · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 13 Class I recalls
- K162738Puritan Bennett 980 Ventilator SystemCovidien · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193056Puritan Bennett 980 Series Ventilator SystemCovidien, LLC · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 117 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 7 of the 22 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K092847 (Covidien, Formerly Nellcor Puritan Bennett, Inc., 2010) has gone furthest, with 11 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. 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 Ventilator 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 be operated by properly trained clinical personnel, under the direction of a physician.
This is the same intended use as previously cleared for AVEA under K013642, K022674, and K062093. There is no change to the AVEA intended use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081837: 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/K081837
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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