510(k) · Cleared
ClearedEvita 2 Dura
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 Aug 26, 1997 as substantially equivalent to K961687 (Drager, Inc., 1996) and 1 other predicate after a 222-day review. Its family tree reaches back 2 generations to 1991. 44 of the 145 devices in its family, counting itself, have a Class I recall. 140 later devices descend from it.
- Decided
- Aug 26, 1997
- Review
- 222 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902859 (1991). 4 ancestors in all. 140 later devices descend from it, 5 citing it directly. 44 of the 145 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 1 generation backK961687 EVITA 4Drager, Inc. · 1996
- This deviceK970165 Evita 2 DuraDrager, Inc. · 1997
- Descendant · cites it directly · 107 of its ownK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- Descendant · 2 generations on · 57 of its ownK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- Descendant · cites it directly · 54 of its ownK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- Descendant · 2 generations on · 53 of its ownK040574 Galileo GoldHamilton Medical, Inc. · 2004
- Descendant · cites it directly · 52 of its ownK021573 Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus…Puritan-Bennett · 2002
Showing 5 of 140 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 140 · See all- K041775GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004 · cites it directly107descendants
- K051767LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005 · 2 generations on57descendants
- K022679RaphaelHamilton Medical AG · 2003 · cites it directly54descendants
- K040574Galileo GoldHamilton Medical, Inc. · 2004 · 2 generations on53descendants
- K021573Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus OptionPuritan-Bennett · 2002 · cites it directly52descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −1 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| 0 (this device) | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| +1 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| +2 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| +1 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| +2 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| +1 | K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus Option | Puritan-Bennett | 2002 | — |
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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 1 |
| 2007 | 5 | 2 |
| 2008 | 6 | 1 |
| 2009 | 7 | 2 |
| 2010 | 9 | 2 |
| 2011 | 13 | 7 |
| 2012 | 12 | 4 |
| 2013 | 9 | 4 |
| 2014 | 6 | 2 |
| 2015 | 6 | 1 |
| 2016 | 7 | 3 |
| 2017 | 7 | 5 |
| 2018 | 2 | 1 |
| 2019 | 7 | 3 |
| 2020 | 3 | 2 |
| 2021 | 5 | 2 |
| 2023 | 5 | 2 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 4 | 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.
44 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 |
|---|---|---|---|
| * | K961687 | EVITA 4Summary page 2…nited States by Siemens Page 1 of 15 Intensive Care Ventilator Data Comparison Sheet Drager Device Evita 4 Evita 2 dura Evita Servo 300 510 (K) number K 961687 K 924930 K902859 Manufacturer Drager Drager Drager Siemens Classification Working Principle Software controlied Gas delivery… | 1996 |
| * | K902859 | Servo Ventilator 300Summary page 2…emens Page 1 of 15 Intensive Care Ventilator Data Comparison Sheet Drager Device Evita 4 Evita 2 dura Evita Servo 300 510 (K) number K 961687 K 924930 K902859 Manufacturer Drager Drager Drager Siemens Classification Working Principle Software controlied Gas delivery system Voltage f… | 1991 |
| * | — | Servo 300 Named without a submission number |
What descends from it? (140)
See all 1405 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (44 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.
- 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
- K133886Perseus A500Draeger Medical GmbH · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 12 Class I recalls
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K093632Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 14 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
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 18 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 generations on · ◆ in the 2007 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
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
Nearest 12 of 44 shown.
Nearest 5 of 44; all are on the web page.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K041775 (Datex-Ohmeda, Inc., 2004) has gone furthest, with 107 descendants of its own.
- 10 other devices also cite its predicate K961687.
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?
Evita 2 dura is a long-term ventilator for the intensive care ventilation of patients with a body weight of at least 3 kg up to 200 Kg. The device is microprocessor-controlled and provides the following ventilation modes: -CMV Intermittent Positive Pressure Ventilation Controlled and assisted volume-constant ventilation - SIMV Synchronized Intermittent Mandatory Ventilation Procedure for weaning patients off the ventilator after they have started…
Read the full statement (194 words)
Evita 2 dura is a long-term ventilator for the intensive care ventilation of patients with a body weight of at least 3 kg up to 200 Kg.
The device is microprocessor-controlled and provides the following ventilation modes:
-CMV Intermittent Positive Pressure Ventilation
Controlled and assisted volume-constant ventilation
- SIMV Synchronized Intermittent Mandatory Ventilation
Procedure for weaning patients off the ventilator after they have started spontaneous breathing
- MMV Mandatory Minute Volume Ventilation
Spontaneous breathing with automatic adjustment of mandatory ventilation to the patient’s minute volume requirement.
- CPAP Continuous Positive Airway Pressure
Spontaneous breathing with positive airway pressure and adjustable pressure support.
- PCV+ Presure Controlled Ventilation
Pressure-controlled ventilation combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure support from CPAP level.
- APRV Airway Pressure Release Ventilation
Spontaneoous breathing on two pressure levels with long time ranges - independently adjustable.
Furthermore Evita 2 dura offers the following special ventilation modes:
- Apnea ventilation For switching over automatically to volume-controlled ventilation if breathing stops.
-ILV Independent Lung Ventilation, optional
Separate, differentiated, synchronised ventilation with one Evita 3 unit for each lung.
Application range
- Intensive care units
- Inner-clinical transport
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/K970165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970165: Evita 2 Dura.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970165
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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