510(k) · Cleared
ClearedEVITA 4
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 Dec 13, 1996 as substantially equivalent to K924930 (Drager, Inc., 1994) and 2 other predicates after a 226-day review. Its family tree reaches back 1 generation to 1991. 57 of the 215 devices in its family, counting itself, have a Class I recall. 211 later devices descend from it.
- Decided
- Dec 13, 1996
- Review
- 226 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K902859 (1991). 3 ancestors in all. 211 later devices descend from it, 11 citing it directly. 57 of the 215 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- This deviceK961687 EVITA 4Drager, Inc. · 1996
- Descendant · cites it directly · 174 of its ownK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- Descendant · cites it directly · 140 of its ownK970165 Evita 2 DuraDrager, Inc. · 1997
- Descendant · cites it directly · 133 of its ownK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 114 of its ownK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- Descendant · 3 generations on · 112 of its ownK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
Showing 5 of 211 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 211 · See all- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · cites it directly174descendants
- K970165Evita 2 DuraDrager, Inc. · 1997 · cites it directly140descendants
- K013642AVEABird Products Corp. · 2002 · cites it directly133descendants
- K032451Bird Tbird Vela VentilatorBird Products Corp. · 2004 · 2 generations on114descendants
- K052554Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005 · 3 generations on112descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| 0 (this device) | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| +1 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| +1 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| +1 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| +2 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| +3 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K924930 | EVITASummary page 1…k Germany April 24, 1996 Evita 4 Owner/Operator ID No. Drager Inc.: Registration No. Dragerwerk AG: Class I 73 CBK Ventilator, Continuous A911151 510(k) Number: K92 49 30 510(k) Number: K92 28 49 510(k) Number: K90 28 59 Drager EVITA 4 Premarket Notification Submission, 510(k) 2431188 96 11 500 "… | 1994 |
| * | K942849 | Capnosat Our OCR of the scanned summary read K922849, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Drager Capnosat”. | 1995 |
| * | K902859 | Servo Ventilator 300Summary page 1…ID No. Drager Inc.: Registration No. Dragerwerk AG: Class I 73 CBK Ventilator, Continuous A911151 510(k) Number: K92 49 30 510(k) Number: K92 28 49 510(k) Number: K90 28 59 Drager EVITA 4 Premarket Notification Submission, 510(k) 2431188 96 11 500 "ADDR | 1991 |
What descends from it? (211)
See all 21111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) Class I | 1998 | 174 |
| K970165 | Evita 2 Dura | 1997 | 140 |
| K013642 | AVEA Class I | 2002 | 133 |
| K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option Class I | 1998 | 55 |
| K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option | 2002 | 52 |
| K030624 | Modification to Fabius GS Anesthesia System | 2004 | 15 |
| K093632 | Infinity Acute Care System Workstation Neonatal Care Class I | 2010 | 10 |
| K042086 | Fabius GS Anesthesia System; Fabius Tiro Anesthesia System | 2004 | 2 |
| K023350 | Esprit Ventilator with Respiratory Mechanics Class I | 2002 | 2 |
| K042419 | Fabius GS/Fabius Tiro Anesthesia System Class I | 2004 | 1 |
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 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 113 Class I recalls
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
- K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K042419Fabius GS/Fabius Tiro Anesthesia SystemDraeger Medical, Inc. · 2004 · Cites it directly · ◆ 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 · Cites it directly · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · 2 generations on · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K072884Fabius MriDraeger Medical AG & Co. KG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 3 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?
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K970460 (Puritan Bennett Corp., 1998) has gone furthest, with 174 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/K961687 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961687: EVITA 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961687
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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