510(k) · Cleared
ClearedEvite XL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draeger Medical AG & Co. KG · CBK Ventilator, Continuous, Facility Use
Cleared on Dec 29, 2008 as substantially equivalent to K010093 (Drager Medizintechnik GmbH, 2001) and 2 other predicates after a 76-day review. Its family tree reaches back 2 generations to 1991. 2 later devices descend from it.
- Decided
- Dec 29, 2008
- Review
- 76 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K902859 (1991). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 1 generation backK974176 Babylog 8000 PlusDrager, Inc. · 1998 · Recalled
- This deviceK083050 Evite XLDraeger Medical AG & Co. KG · 2008
- Descendant · cites it directly · 1 of its ownK220107 Mindray SV600 Ventilator, Mindray SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK243767 SV600, SV800 VentilatorShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView 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 | K974176 | Babylog 8000 Plus | Drager, Inc. | 1998 | 1 |
| 0 (this device) | K083050 | Evite XL | Draeger Medical AG & Co. KG | 2008 | — |
| +1 | K220107 | Mindray SV600 Ventilator, Mindray SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2023 | — |
| +1 | K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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.
Planning a device in CBK? 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 |
|---|---|---|---|
| * | K010093 | Non-Invasive Ventilation Niv Option, Model 84 14 474Summary page 2…A Dr~ger and Siemens Company Legally Marketed Devices to which Substantial Equivalence is claimed: 510(k) number Trade name Company K 010093; K980642 Evita XL Draeger Medical AG & Co. KG K 974176 Babylog 8000 plus D… | 2001 |
| * | K980642 | EVITA 4 (8411900)Summary page 2…er and Siemens Company Legally Marketed Devices to which Substantial Equivalence is claimed: 510(k) number Trade name Company K 010093; K980642 Evita XL Draeger Medical AG & Co. KG K 974176 Babylog 8000 plus Draeger Me… | 1998 |
| * | K974176 | Babylog 8000 PlusSummary page 2…ivalence is claimed: 510(k) number Trade name Company K 010093; K980642 Evita XL Draeger Medical AG & Co. KG K 974176 Babylog 8000 plus Draeger Medical AG & Co. KG Device Description: Evita XL is a time-cycled micropr… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K220107 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K010093.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Long-term ventilator for intensive care.
For adults, children, and neonates with a minimum body weight of 3 kg (6.6 lbs). For premature infants with a minimum body weight of 0.5 kg (1.1 lbs) with the NeoFlow option.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083050: Evite XL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083050
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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