510(k) · Cleared
ClearedVela 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 May 11, 2010 as substantially equivalent to K022132 (Siemens Medical Solutions USA, Inc., 2002) and 2 other predicates after a 222-day review. Its family tree reaches back 7 generations to 1991. 5 of the 52 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- May 11, 2010
- Review
- 222 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K902859 (1991). 49 ancestors in all, the oldest K895541 (1990). 2 later devices descend from it, 1 citing it directly. 5 of the 52 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 5 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 4 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 3 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 2 generations backK022674 Bird Avea VentilatorBird Products Corp. · 2002 · Recalled
- 1 generation backK060647 LTV 1200 VentilatorPulmonetic Systems, Inc. · 2006
- This deviceK093094 Vela VentilatorCardinal Health 207, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK101643 Model LTV 1100 VentilatorCare Fusion · 2011
- Descendant · 2 generations on · 0 of its ownK201082 LTV2 Series VentilatorsVyaire Medical, Inc. · 2021
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −6 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −5 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −4 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −3 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −2 | K022674 | Bird Avea Ventilator | Bird Products Corp. | 2002 | 5 |
| −1 | K060647 | LTV 1200 Ventilator | Pulmonetic Systems, Inc. | 2006 | — |
| 0 (this device) | K093094 | Vela Ventilator | Cardinal Health 207, Inc. | 2010 | — |
| +1 | K101643 | Model LTV 1100 Ventilator | Care Fusion | 2011 | — |
| +2 | K201082 | LTV2 Series Ventilators | Vyaire Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 7 | 1 |
| 1999 | 4 | 0 |
| 2000 | 3 | 1 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
5 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 |
|---|---|---|---|
| * | K022132 | Servo Ventilator System, Model 64 87 800 E407ESummary page 1…ne 5,-2009 VELA Ventilator Classification name: 868.5895 Continuous Ventilator, 73 CBK 202171 Class Il Anesthesiology The predicate devices are: . e Maquet Servo-l K022132 e LTV 1200: K060647 e Cardinal Health AVEA Ventilator: KO73069 Device Description: A VELA with the CO; monitorin… | 2002 |
| * | K060647 | LTV 1200 VentilatorSummary page 1…tilator Classification name: 868.5895 Continuous Ventilator, 73 CBK 202171 Class Il Anesthesiology The predicate devices are: . e Maquet Servo-l K022132 e LTV 1200: K060647 e Cardinal Health AVEA Ventilator: KO73069 Device Description: A VELA with the CO; monitoring option is intended… | 2006 |
| * | K073069 | Modification to Avea VentilatorSummary page 3…pplications. Substantial Predicate Device Information Equivalence: The predicate device(s) are: e Maquet Servo-l: K022132 e LTV 1200: KO60647 e Cardinal Health AVEA: K073069 The modifications to VELA associated with this submittal as follows: « An End Tidal CO; monitoring option consisting of an exte… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101643 | Model LTV 1100 Ventilator | 2011 | 1 |
Has anything in its family been recalled? (5 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.
- K073069Modification to Avea VentilatorViasys Respiratory Care, Inc. · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 113 Class I recalls
- 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
- K013642AVEABird Products Corp. · 2002 · 3 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 4 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 18 of the 49 ancestors have a recall of any class; 5 have a Class I recall.
- Of its descendants, K101643 (Care Fusion, 2011) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K022132.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 VELA Ventilator is intended to provide continuous or intermittent respiratory support in an institutional health care environment (e.g. hospitals) for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use only by qualified trained personnel under the direction of a physician. It may be used on adult and pediatric patients. Specifically, the ventilator is applicable for adult and pediatric…
Read the full statement (128 words)
The VELA Ventilator is intended to provide continuous or intermittent respiratory support in an institutional health care environment (e.g. hospitals) for individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use only by qualified trained personnel under the direction of a physician. It may be used on adult and pediatric patients. Specifically, the ventilator is applicable for adult and pediatric patients weighting at least 5 kg (11Ib), who require the following types of ventilation support, as prescribed by an attending physician.
- Positive pressure ventilation
- Assist / control, SIMV, or CPAP modes of ventilation
The ventilator is suitable for use in institutional and transport settings. It is not intended of use in an emergency medical transport ventilator or for home care applications.
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/K093094 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093094: Vela Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093094
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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