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 7, 2026 as substantially equivalent to K222024 (Draegerwerk AG & CO Kgaa, 2023) after a 168-day review. Its family tree reaches back 2 generations to 2010. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- May 7, 2026
- Review
- 168 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K093633 (2010). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK093633 Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa · 2010 · Recalled (Class I)
- 1 generation backK222024 Evita V800, Evita V600Draegerwerk AG & CO Kgaa · 2023
- This deviceK253647 Evita (V800); Evita (V600)Draegerwerk AG & CO Kgaa · 2026
Class I recalls in this family
- K093633 Infinity Acute Care System Workstation Critical…2 generations back · 2010
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K222024 | Evita V800, Evita V600Summary page 5…Product Code: CBK (Ventilator, Continuous, Facility Use) Class: II Predicate Device: Evita V800, Evita V600, K222024 Reference device: Getinge Maquet Servo-U K180098 Device Description Evita V800 and Evita V600 are specified for the ventilation… | 2023 |
| † | K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 13.1 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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/K253647 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253647: 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/K253647
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026