510(k) · Cleared
ClearedTbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator with Pressure Limit Model 00-004130, Bear 3
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 Aug 24, 1998 as substantially equivalent to K950484 (Bird Products Corp., 1996) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1984. 16 of the 46 devices in its family, counting itself, have a Class I recall. 42 later devices descend from it.
- Decided
- Aug 24, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K841279 (1984). 3 ancestors in all. 42 later devices descend from it, 2 citing it directly. 16 of the 46 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK841279 BEAR 33Bear Medical Systems, Inc. · 1984
- This deviceK981971 Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume…Bird Products Corp. · 1998
- Descendant · cites it directly · 40 of its ownK984056 LTV 1000Pulmonetic Systems, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 29 of its ownK022750 PLV Continuum Ventilator, Model P1000Respironics California, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 26 of its ownK083526 Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- Descendant · 3 generations on · 19 of its ownK093416 Trilogy 200 VentilatorRespironics, Inc. · 2010 · Recalled (Class I)
- Descendant · 2 generations on · 12 of its ownK070594 Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · Recalled (Class I)
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 42 · See all- K984056LTV 1000Pulmonetic Systems, Inc. · 1999 · cites it directly40descendants
- K022750PLV Continuum Ventilator, Model P1000Respironics California, Inc. · 2003 · 2 generations on29descendants
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on26descendants
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations on19descendants
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841279 | BEAR 33 | Bear Medical Systems, Inc. | 1984 | — |
| 0 (this device) | K981971 | Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator… | Bird Products Corp. | 1998 | — |
| +1 | K984056 | LTV 1000 | Pulmonetic Systems, Inc. | 1999 | 12 |
| +2 | K022750 | PLV Continuum Ventilator, Model P1000 | Respironics California, Inc. | 2003 | 2 |
| +2 | K083526 | Trilogy 100 Ventilator | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| +3 | K093416 | Trilogy 200 Ventilator | Respironics, Inc. | 2010 | Class I |
| +2 | K070594 | Palmtop Ventilator, Models PTV-8, PTV-10 | Pulmonetic Systems, Inc. | 2007 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 1 |
| 2008 | 2 | 1 |
| 2009 | 3 | 2 |
| 2010 | 2 | 1 |
| 2011 | 3 | 2 |
| 2012 | 6 | 1 |
| 2013 | 2 | 1 |
| 2014 | 2 | 0 |
| 2016 | 4 | 1 |
| 2017 | 2 | 2 |
| 2018 | 1 | 1 |
| 2019 | 3 | 2 |
| 2021 | 1 | 1 |
| 2024 | 4 | 0 |
| 2025 | 2 | 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.
16 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 |
|---|---|---|---|
| * | K950484 | Tbird VS Ventilator and Tbird Avs VentilatorSummary page 2…The intended use of the TBird VS Volume Ventilator is being modified to include homecare applications. Predicate Device: TBird VS, AVS Volume Ventilator FDA 510(k) No: K950484 Aquetron LP-10 Volume Ventilator FDA 510(k) No: K905244 Bear 33 Volume Ventilator FDA 510(k) No: K841279 Statement of Indicati… | 1996 |
| * | K905244 | Model LP6 Ventilator, ModificationSummary page 2…ing modified to include homecare applications. Predicate Device: TBird VS, AVS Volume Ventilator FDA 510(k) No: K950484 Aquetron LP-10 Volume Ventilator FDA 510(k) No: K905244 Bear 33 Volume Ventilator FDA 510(k) No: K841279 Statement of Indications for Use The TBird Homecare ventilator is intended to… | 1990 |
| * | K841279 | BEAR 33Summary page 2…edicate Device: TBird VS, AVS Volume Ventilator FDA 510(k) No: K950484 Aquetron LP-10 Volume Ventilator FDA 510(k) No: K905244 Bear 33 Volume Ventilator FDA 510(k) No: K841279 Statement of Indications for Use The TBird Homecare ventilator is intended to provide continuous or intermittent mechanical ven… | 1984 |
What descends from it? (42)
See all 422 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (16 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.
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 15 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
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- 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
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
Nearest 12 of 16 shown.
Nearest 5 of 16; all are on the web page.
What does this lineage say?
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 Homecare 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:
Positive pressure ventilation
Assist/Control, SIMV, CPAP modes of ventilation
The ventilator is suitable for use in institutional and home settings.
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/K981971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981971: Tbird VS/Avs Volume Ventilator, Models 15568, 15570 , LP10 Volume Ventilator with Pressure Limit Model 00-004130, Bear 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981971
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