510(k) · Cleared
ClearedEVITA 4 (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 Sep 4, 1998 after a 197-day review. The FDA summary names its predicate without a number. 32 of the 113 devices in its family, counting itself, have a Class I recall. 112 later devices descend from it.
- Decided
- Sep 4, 1998
- Review
- 197 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 0
112 later devices descend from it, 7 citing it directly. 32 of the 113 devices in this family, counting this one, have a Class I recall.
- This deviceK980642 EVITA 4 (8411900)Drager, Inc. · 1998
- Descendant · cites it directly · 102 of its ownK022132 Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc. · 2002
- Descendant · cites it directly · 75 of its ownK040221 Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Recalled
- Descendant · 2 generations on · 73 of its ownK041223 Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Recalled (Class I)
- Descendant · 3 generations on · 61 of its ownK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- Descendant · cites it directly · 53 of its ownK040574 Galileo GoldHamilton Medical, Inc. · 2004
Showing 5 of 112 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 112 · See all- K022132Servo Ventilator System, Model 64 87 800 E407ESiemens Medical Solutions USA, Inc. · 2002 · cites it directly102descendants
- K040221Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · cites it directly75descendants
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations on73descendants
- K063404Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007 · 3 generations on61descendants
- K040574Galileo GoldHamilton Medical, Inc. · 2004 · cites it directly53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980642 | EVITA 4 (8411900) | Drager, Inc. | 1998 | — |
| +1 | K022132 | Servo Ventilator System, Model 64 87 800 E407E | Siemens Medical Solutions USA, Inc. | 2002 | — |
| +1 | K040221 | Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | 1 |
| +2 | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407E | Maquet Critical Care AB | 2004 | Class I |
| +3 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| +1 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 6 | 2 |
| 2005 | 2 | 0 |
| 2006 | 4 | 1 |
| 2007 | 5 | 0 |
| 2008 | 10 | 2 |
| 2009 | 5 | 1 |
| 2010 | 6 | 1 |
| 2011 | 9 | 6 |
| 2012 | 8 | 2 |
| 2013 | 6 | 3 |
| 2014 | 3 | 1 |
| 2015 | 7 | 1 |
| 2016 | 2 | 2 |
| 2017 | 6 | 3 |
| 2018 | 1 | 0 |
| 2019 | 5 | 1 |
| 2020 | 4 | 3 |
| 2021 | 6 | 2 |
| 2023 | 5 | 1 |
| 2024 | 4 | 0 |
| 2025 | 3 | 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.
32 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 | |
| * | — | Evita 2 dura Named without a submission number | |
| * | — | Servo 300 Named without a submission number |
What descends from it? (112)
See all 1127 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022132 | Servo Ventilator System, Model 64 87 800 E407E | 2002 | 102 |
| K040221 | Servo-I Ventilator System, Model 64 87 800 E407E | 2004 | 75 |
| K040574 | Galileo Gold | 2004 | 53 |
| K051263 | Evitaxl with Option Smartcare | 2005 | 51 |
| K093632 | Infinity Acute Care System Workstation Neonatal Care Class I | 2010 | 10 |
| K072450 | Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000 | 2007 | 6 |
| K083050 | Evite XL | 2008 | 2 |
Has anything in its family been recalled? (32 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.
- 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
- K034040Esprit Ventilator, Model V1000Respironics, Inc. · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K073069Modification to Avea VentilatorViasys Respiratory Care, Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 113 Class I recalls
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 2 generations on · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 2 generations on · ◆ in the 2008 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
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 3 generations on · ◆ in the 2011 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
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
Nearest 12 of 32 shown.
Nearest 5 of 32; all are on the web page.
What does this lineage say?
- Of its descendants, K022132 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 102 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?
Evita 4 is a time cycled, constant volume, long term, intensive care ventilator for adults and children with a body weight of at least 3 kg.
Intended Environment for the device:
- hospital use
- inner clinical transportt
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/K980642 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980642: EVITA 4 (8411900).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980642
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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