510(k) · Cleared
ClearedNeoflow Option Model Numbers 8413563, 8411900
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 7, 1998 after an 84-day review. The FDA summary names its predicate without a number. 19 of the 54 devices in its family, counting itself, have a Class I recall. 53 later devices descend from it.
- Decided
- Dec 7, 1998
- Review
- 84 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
53 later devices descend from it, 6 citing it directly. 19 of the 54 devices in this family, counting this one, have a Class I recall.
- This deviceK983219 Neoflow Option Model Numbers 8413563, 8411900Drager, Inc. · 1998
- Descendant · cites it directly · 51 of its ownK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- Descendant · 2 generations on · 36 of its ownK061090 Galileo Gold AsvHamilton Medical AG · 2006
- Descendant · 3 generations on · 26 of its ownK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- Descendant · 2 generations on · 23 of its ownK072412 Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor…Drager Medical AG & Co. Kgaa · 2008
- Descendant · 3 generations on · 21 of its ownK080181 Modification to Galileo GoldHamilton Medical AG · 2008
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 53 · See all- K051263Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · cites it directly51descendants
- K061090Galileo Gold AsvHamilton Medical AG · 2006 · 2 generations on36descendants
- K070513Hamilton-G5Hamilton Medical AG · 2007 · 3 generations on26descendants
- K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa · 2008 · 2 generations on23descendants
- K080181Modification to Galileo GoldHamilton Medical AG · 2008 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983219 | Neoflow Option Model Numbers 8413563, 8411900 | Drager, Inc. | 1998 | — |
| +1 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| +2 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| +3 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| +2 | K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor… | Drager Medical AG & Co. Kgaa | 2008 | — |
| +3 | K080181 | Modification to Galileo Gold | Hamilton Medical AG | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 3 | 1 |
| 2007 | 3 | 0 |
| 2008 | 3 | 1 |
| 2009 | 2 | 0 |
| 2010 | 3 | 1 |
| 2011 | 5 | 3 |
| 2012 | 6 | 2 |
| 2013 | 2 | 2 |
| 2014 | 1 | 1 |
| 2015 | 3 | 1 |
| 2016 | 1 | 1 |
| 2017 | 3 | 2 |
| 2019 | 3 | 1 |
| 2020 | 3 | 2 |
| 2021 | 2 | 1 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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.
19 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 |
|---|---|---|---|
| * | — | Evita 4 Named without a submission number | |
| * | — | Babylog 8000 plus Named without a submission number | |
| * | — | Servo 300 Named without a submission number |
What descends from it? (53)
See all 536 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051263 | Evitaxl with Option Smartcare | 2005 | 51 |
| K081521 | Modification to Hamilton-G5 Class I | 2008 | 16 |
| K103803 | Hamilton-G5 Class I | 2011 | 14 |
| K102775 | Hamilton-C2 | 2011 | 14 |
| K093632 | Infinity Acute Care System Workstation Neonatal Care Class I | 2010 | 10 |
| K051262 | Esprit Ventilator Neonatal Option, Model V1000 | 2005 | 0 |
Has anything in its family been recalled? (19 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.
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K103803Hamilton-G5Hamilton Medical AG · 2011 · Cites it directly · ◆ in the 2011 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
- 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
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
Nearest 12 of 19 shown.
Nearest 5 of 19; all are on the web page.
What does this lineage say?
- Of its descendants, K051263 (Drager Medical AG & Co. Kgaa, 2005) has gone furthest, with 51 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) | — |
What is it indicated for?
The Evita 4 / 2 Dura with NeoFlow Option is a long-term ventilator to be used for intensive care and inner clinical transport of adults, children, infants and neonates with a minimum body weight of 0.5 kg. The device is microprocessor controlled and provides the following ventilation modes: - CMVl/assist Controlled Mandatory Ventiiation Controlled and assisted volume constant ventilation, with the options: - CPPV Continuous Positive Pressure Ventilation…
Read the full statement (245 words)
The Evita 4 / 2 Dura with NeoFlow Option is a long-term ventilator to be used for intensive care and inner clinical transport of adults, children, infants and neonates with a minimum body weight of 0.5 kg.
The device is microprocessor controlled and provides the following ventilation modes:
- CMVl/assist Controlled Mandatory Ventiiation
Controlled and assisted volume constant ventilation, with the options:
- CPPV Continuous Positive Pressure Ventilation
- PLV Pressure Limited Ventilation
- AutoFlow For automatic regulation of inspiratory flow
- IRV Inversed Ratio Ventilation
- SiMV Synchronised Intermittent Mandatory Ventilation
Procedure for weaning patients off the ventilator after they have started spontaneous breathing. With the options:
- PLV
- AutoFlow
- MMV Mandatory Minute Volume Ventilation
Spontaneous breathing with automatic adjustment of mandatory ventilation to the patients minute volume requirement. With the options:
- PLV
- AutoFlow
- SB Spontaneous Breathing
Spontaneous breathing at ambient pressure
- CPAP Continuos Positive Airway Pressure
Spontaneous breathing with positive airway pressure
- ASBIPSV Assisted Spontaneous Breathing / Pressure Support Ventilation
Pressure supported spantaneous breathing
- PCV+ Pressure controlled ventilation, combined with free spontaneous breathing during the complete breathing cycle, and adjustable pressure increase to CPAP level
- APRV Alrway Pressure Release Ventilation
Spontaneous breathing on two pressure levels with long time ranges - independently adjustable.
- Apnea Ventilation For switching over automatically to volume controlled ventilation if breathing stops.
- Independent Lung Ventilation
Separate, differentiated synchronised ventilation with one Evita 4 / 2 Dura for each
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/K983219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983219: Neoflow Option Model Numbers 8413563, 8411900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983219
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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