510(k) · Cleared
ClearedEVITA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drager, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Jan 10, 1994 after a 467-day review. The FDA summary names no predicate by number. 57 of the 213 devices in its family, counting itself, have a Class I recall. 212 later devices descend from it.
- Decided
- Jan 10, 1994
- Review
- 467 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
212 later devices descend from it, 1 citing it directly. 57 of the 213 devices in this family, counting this one, have a Class I recall.
- This deviceK924930 EVITADrager, Inc. · 1994
- Descendant · cites it directly · 211 of its ownK961687 EVITA 4Drager, Inc. · 1996
- Descendant · 2 generations on · 174 of its ownK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- Descendant · 2 generations on · 140 of its ownK970165 Evita 2 DuraDrager, Inc. · 1997
- Descendant · 2 generations on · 133 of its ownK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- Descendant · 3 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
Showing 5 of 212 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 212 · See all- K961687EVITA 4Drager, Inc. · 1996 · cites it directly211descendants
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 2 generations on174descendants
- K970165Evita 2 DuraDrager, Inc. · 1997 · 2 generations on140descendants
- K013642AVEABird Products Corp. · 2002 · 2 generations on133descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 3 generations on114descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924930 | EVITA | Drager, Inc. | 1994 | — |
| +1 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| +2 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| +2 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| +2 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| +3 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 2 |
| 1999 | 2 | 1 |
| 2002 | 5 | 2 |
| 2003 | 1 | 0 |
| 2004 | 12 | 2 |
| 2005 | 8 | 0 |
| 2006 | 11 | 1 |
| 2007 | 7 | 2 |
| 2008 | 14 | 3 |
| 2009 | 8 | 2 |
| 2010 | 11 | 3 |
| 2011 | 15 | 7 |
| 2012 | 18 | 5 |
| 2013 | 10 | 4 |
| 2014 | 8 | 2 |
| 2015 | 8 | 1 |
| 2016 | 10 | 3 |
| 2017 | 11 | 5 |
| 2018 | 3 | 1 |
| 2019 | 9 | 3 |
| 2020 | 4 | 3 |
| 2021 | 7 | 3 |
| 2022 | 1 | 0 |
| 2023 | 6 | 2 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 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.
57 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?
The FDA summary names no predicate by number.
What descends from it? (212)
See all 2121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961687 | EVITA 4 | 1996 | 211 |
Has anything in its family been recalled? (57 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.
- K013642AVEABird Products Corp. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 113 Class I recalls
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 2 generations on · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
- K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 14 Class I recalls
- K993071Puritan-Bennett Ventilator System with ET/Tracheostomy Tube Compensation, TC, Option, Model 840Puritan Bennett Corp. · 1999 · 2 generations on · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 2 generations on · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 3 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 3 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 3 generations on · ◆ in the 2008 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
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 57 shown.
Nearest 5 of 57; all are on the web page.
What does this lineage say?
- Of its descendants, K961687 (Drager, Inc., 1996) has gone furthest, with 211 descendants of its own.
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) | — |
https://510kreport.com/device/K924930 · printed Nov 5, 2026
Cite this page
510(k) Report. “K924930: EVITA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K924930
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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