510(k) · Cleared
ClearedEvita V800, Evita V600
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draegerwerk AG & CO Kgaa · CBK Ventilator, Continuous, Facility Use
Cleared on May 16, 2023 as substantially equivalent to K093633 (Draegerwerk AG & CO Kgaa, 2010) after a 309-day review. Its family tree reaches back 1 generation to 2010. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- May 16, 2023
- Review
- 309 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K093633 (2010). 1 later device descends from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK093633 Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa · 2010 · Recalled (Class I)
- This deviceK222024 Evita V800, Evita V600Draegerwerk AG & CO Kgaa · 2023
- Descendant · cites it directly · 0 of its ownK253647 Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa · 2026
Class I recalls in this family
- K093633 Infinity Acute Care System Workstation Critical…direct predicate · 2010
Most influential descendants
Showing 1 of 1 · See all- K253647Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K093633 | Infinity Acute Care System Workstation Critical Care | Draegerwerk AG & CO Kgaa | 2010 | Class I |
| 0 (this device) | K222024 | Evita V800, Evita V600 | Draegerwerk AG & CO Kgaa | 2023 | — |
| +1 | K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
1 device in this family has 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? (1)
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 |
|---|---|---|---|
| * | K093633 | Infinity Acute Care System Workstation Critical CareSummary page 4…868.5895 Product Code: CBK, Class: II Predicate Device: Infinity Acute Care System Workstation Critical Care, K093633 Referenced Device: Puritan Bennett™ 980 Series Ventilator System, K193056 was used as a reference device for extension of flow ra… | 2010 |
| † | K193056 | Puritan Bennett 980 Series Ventilator System | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | 2026 | 0 |
Has anything in its family been recalled? (1 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.
- K093633Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa · 2010 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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 intensive care ventilator (Evita V800 / Evita V600) is intended for the ventilation of adults, pediatric patients and neonates weighing a minimum of 0.4 kg (0.88 lb). The device is indicated for patients who require temporary or longer-term breathing support for different medical reasons. The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport. The device is intended to be used by qualified and trained medical personnel. The device is indicated to provide critical care specific therapy. The device provides ventilation monitoring and modes for volume controlled, pressure controlled and spontaneous breathing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222024 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222024: Evita V800, Evita V600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222024
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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