510(k) · Cleared
ClearedBird Tbird Vela Ventilator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bird Products Corp. · CBK Ventilator, Continuous, Facility Use
Cleared on Apr 22, 2002 as substantially equivalent to K950484 (Bird Products Corp., 1996) and 3 other predicates after a 46-day review. Its family tree reaches back 2 generations to 1988. 38 of the 128 devices in its family, counting itself, have a Class I recall. 120 later devices descend from it.
- Decided
- Apr 22, 2002
- Review
- 46 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K883038 (1988). 7 ancestors in all. 120 later devices descend from it, 2 citing it directly. 38 of the 128 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK883038 P/N 9320 Low Flow Air/Oxygen MicroblenderBird Products Corp. · 1988
- 1 generation backK973646 Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerBird Products Corp. · 1998
- This deviceK020746 Bird Tbird Vela VentilatorBird Products Corp. · 2002
- Descendant · cites it directly · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 2 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · 2 generations on · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- Descendant · 3 generations on · 86 of its ownK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- Descendant · 4 generations on · 61 of its ownK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 120 · See all- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · cites it directly114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 2 generations on112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · 2 generations on87descendants
- K061627Modification to I Vent 201Versamed Medical Systems, Inc. · 2006 · 3 generations on86descendants
- K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007 · 4 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883038 | P/N 9320 Low Flow Air/Oxygen Microblender | Bird Products Corp. | 1988 | — |
| −1 | K973646 | Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer | Bird Products Corp. | 1998 | — |
| 0 (this device) | K020746 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2002 | — |
| +1 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +2 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +2 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +3 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +4 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 1 |
| 2008 | 6 | 1 |
| 2009 | 5 | 1 |
| 2010 | 3 | 1 |
| 2011 | 12 | 7 |
| 2012 | 13 | 5 |
| 2013 | 10 | 4 |
| 2014 | 5 | 1 |
| 2015 | 7 | 1 |
| 2016 | 6 | 2 |
| 2017 | 10 | 4 |
| 2018 | 2 | 0 |
| 2019 | 7 | 3 |
| 2020 | 4 | 3 |
| 2021 | 6 | 3 |
| 2022 | 1 | 0 |
| 2023 | 2 | 1 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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.
38 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? (4)
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 |
|---|---|---|---|
| * | K950484 | Tbird VS Ventilator and Tbird Avs VentilatorSummary page 1…4 (fax) August 11, 2000 TBird VELA Ventilator Classification name: 868.5895 Continuous Ventilator, 73 CBK 2021710 Class Anesthesiology The predicate devices are: 1 K950484 TBIRD AVS Bird Products Corporation 2 K920113 Bird Graphics Monitor Bird Products Corporation 3 K973646 Bird Sentry Blender Bird… | 1996 |
| * | K920113 | Bird Graphics MonitorSummary page 1…Classification name: 868.5895 Continuous Ventilator, 73 CBK 2021710 Class Anesthesiology The predicate devices are: 1 K950484 TBIRD AVS Bird Products Corporation 2 K920113 Bird Graphics Monitor Bird Products Corporation 3 K973646 Bird Sentry Blender Bird Products Corporation 4 K911336 Bird Nebulizer… | 1993 |
| * | K973646 | Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/AnalyzerSummary page 1…CBK 2021710 Class Anesthesiology The predicate devices are: 1 K950484 TBIRD AVS Bird Products Corporation 2 K920113 Bird Graphics Monitor Bird Products Corporation 3 K973646 Bird Sentry Blender Bird Products Corporation 4 K911336 Bird Nebulizer Synchronizer Bird Product Corporation The TBird VELA Vent… | 1998 |
| * | K911336 | Bird Nebulization SynchronizerSummary page 1…s are: 1 K950484 TBIRD AVS Bird Products Corporation 2 K920113 Bird Graphics Monitor Bird Products Corporation 3 K973646 Bird Sentry Blender Bird Products Corporation 4 K911336 Bird Nebulizer Synchronizer Bird Product Corporation The TBird VELA Ventilator employs a turbine gas delivery system along with… | 1991 |
What descends from it? (120)
See all 1202 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (38 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.
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 3 generations on · ◆ in the 2017 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
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
Nearest 12 of 38 shown.
Nearest 5 of 38; all are on the web page.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 9.5 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K032451 (Bird Products Corp., 2004) has gone furthest, with 114 descendants of its own.
- 4 other devices also cite its predicate K950484.
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 TBird VELA Ventilator is intended to provide continuous or intermittent mechanical ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 Ibs.), who require the following general types of…
Read the full statement (109 words)
The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 Ibs.), who require the following general types of ventilatory support, as prescribed by an attending physician:
o Positive pressure ventilation
e Assist/Control, SIMV, CPAP modes of ventilation
The ventilator is suitable for use in institutional and transport settings. It is not intended for use as an emergency medical transport ventilator.
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/K020746 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020746: Bird Tbird Vela Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020746
Report an extraction error
Are you the manufacturer?
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