510(k) · Cleared
ClearedVentoux VC2; Ventoux VC3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flight Medical Innovations, Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 2, 2024 as substantially equivalent to K143035 (Flight Medical Innovations, Ltd., 2016) after a 791-day review. Its family tree reaches back 15 generations to 1991. 5 of the 79 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 2, 2024
- Review
- 791 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K902859 (1991). 78 ancestors in all, the oldest K841279 (1984). No later device cites it as a predicate yet. 5 of the 79 devices in this family, counting this one, have a Class I recall.
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 11 generations between
- 3 generations backK120726 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2012
- 2 generations backK130171 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2014
- 1 generation backK143035 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2016
- This deviceK223120 Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd. · 2024
Show all 15 generations
- Root · 15 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 14 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 13 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 12 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 11 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 10 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 9 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 8 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 7 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 6 generations backK082724 Newport HTS50 Ventilator with Dual Pac Battery SystemNewport Medical Instruments, Inc. · 2008 · Recalled
- 5 generations backK100753 Flight 60 Ventilator, Model F-60Flight Medical, Ltd. · 2010
- 4 generations backK111683 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2011
- 3 generations backK120726 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2012
- 2 generations backK130171 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2014
- 1 generation backK143035 Flight 60 VentilatorFlight Medical Innovations, Ltd. · 2016
- This deviceK223120 Ventoux VC2; Ventoux VC3Flight Medical Innovations, Ltd. · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −14 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −13 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −12 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −11 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −10 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −9 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −8 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −7 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −6 | K082724 | Newport HTS50 Ventilator with Dual Pac Battery System | Newport Medical Instruments, Inc. | 2008 | 2 |
| −5 | K100753 | Flight 60 Ventilator, Model F-60 | Flight Medical, Ltd. | 2010 | — |
| −4 | K111683 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2011 | — |
| −3 | K120726 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2012 | — |
| −2 | K130171 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2014 | — |
| −1 | K143035 | Flight 60 Ventilator | Flight Medical Innovations, Ltd. | 2016 | — |
| 0 (this device) | K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 10 | 2 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 1 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 1 |
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? (1)
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 |
|---|---|---|---|
| * | K143035 | Flight 60 VentilatorSummary page 6…entilators as class II devices (product code 73 CBK and DQA) and they are reviewed by the Anesthesiology panel Predicate Device: Flight 60 Ventilator cleared under K143035 Reference Device: HAMILTON C6 Ventilator cleared under K201658 Device Description: The Ventoux Ventilator is an electrically… | 2016 |
| † | K201658 | Hamilton-C6 | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 15 Class I recalls
- K013642AVEABird Products Corp. · 2002 · 4 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 5 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 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 27 of the 78 ancestors have a recall of any class; 5 have a Class I recall.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Ventoux is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the Ventoux is applicable for adult and pediatric (i.e., infant, child and adolescent) patients who weigh at least 5 kg (11 lbs).
The Ventoux is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223120 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223120: Ventoux VC2; Ventoux VC3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223120
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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