510(k) · Cleared
Recalled · 2007Bird 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 Mar 17, 2004 as substantially equivalent to K020746 (Bird Products Corp., 2002) and 2 other predicates after a 219-day review. Its family tree reaches back 5 generations to 1991. 40 of the 145 devices in its family, counting itself, have a Class I recall. 114 later devices descend from it. It has been recalled once.
- Decided
- Mar 17, 2004
- Review
- 219 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K902859 (1991). 30 ancestors in all, the oldest K883038 (1988). 114 later devices descend from it, 7 citing it directly. 40 of the 145 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 deviceK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004
- Descendant · cites it directly · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- Descendant · cites it directly · 87 of its ownK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- Descendant · 2 generations on · 86 of its ownK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- Descendant · 3 generations on · 61 of its ownK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- Descendant · 4 generations on · 37 of its ownK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
Showing 5 of 114 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 114 · See all- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · cites it directly112descendants
- K053270IVENT 201Versamed Medical Systems, Inc. · 2006 · cites it directly87descendants
- K061627Modification to I Vent 201Versamed Medical Systems, Inc. · 2006 · 2 generations on86descendants
- K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007 · 3 generations on61descendants
- K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008 · 4 generations on37descendants
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) | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | — |
| +1 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| +1 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +2 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| +3 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| +4 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 5 | 2 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 1 |
| 2008 | 6 | 1 |
| 2009 | 5 | 1 |
| 2010 | 3 | 1 |
| 2011 | 11 | 7 |
| 2012 | 10 | 4 |
| 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.
40 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 |
|---|---|---|---|
| * | K020746 | Bird Tbird Vela VentilatorSummary page 1…egistration Number Device Class: Class II Classification Panel: Anesthesiology Predicate Device: The predicate devices are: 1 K020746 TBIRD VELA Ventilator Bird Products Corporation 2 K01 3642 AVEA… | 2002 |
| * | K013642 | AVEASummary page 1…The predicate devices are: 1 K020746 TBIRD VELA Ventilator Bird Products Corporation 2 K01 3642 AVEA Ventilator Bird Products Corporation 3 K981072 Espri… | 2002 |
| * | K981072 | Esprit VentilatorSummary page 1…Bird Products Corporation 2 K01 3642 AVEA Ventilator Bird Products Corporation 3 K981072 Esprit Respironics Device Description: The TBird VELA Ventilator employs a turb… | 1998 |
What descends from it? (114)
See all 1147 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052554 | Modification to: Ivent 201 Portable Ventilator | 2005 | 112 |
| K053270 | IVENT 201 | 2006 | 87 |
| K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 Class I | 2007 | 12 |
| K071526 | Uni-Vent 731 Series Ventilators, Model 731, 731EMV | 2008 | 7 |
| K111683 | Flight 60 Ventilator | 2011 | 4 |
| K120726 | Flight 60 Ventilator | 2012 | 3 |
| K130171 | Flight 60 Ventilator | 2014 | 2 |
Has anything in its family been recalled? (40 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 31, 2007 | Not classified | Z-0638-2007 | Other | The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms. |
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
- K981072Esprit VentilatorRespironics, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- 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
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K093261MOVESThornhill Research, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
Nearest 12 of 40 shown.
Nearest 5 of 40; all are on the web page.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 30 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K052554 (Versamed Medical Systems, Inc., 2005) has gone furthest, with 112 descendants of its own.
- 1 other device also cites its predicate K020746.
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 lbs.), 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 lbs.), who require the following general types of ventilatory support, as prescribed by an attending physician:
* Positive pressure ventilation
* 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 as stated in the FDA summary.
https://510kreport.com/device/K032451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032451: Bird Tbird Vela Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032451
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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