510(k) · Cleared
Recalled · 2008Evitaxl with Option Smartcare
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drager Medical AG & Co. Kgaa · CBK Ventilator, Continuous, Facility Use
Cleared on Jul 12, 2005 as substantially equivalent to K980642 (Drager, Inc., 1998) and 6 other predicates after a 57-day review. Its family tree reaches back 6 generations to 1991. 22 of the 78 devices in its family, counting itself, have a Class I recall. 51 later devices descend from it. It has been recalled once.
- Decided
- Jul 12, 2005
- Review
- 57 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 6 generations to K902859 (1991). 26 ancestors in all, the oldest K902506 (1991). 51 later devices descend from it, 9 citing it directly. 22 of the 78 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations backK961687 EVITA 4Drager, Inc. · 1996
- 4 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 3 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 2 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 1 generation backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- This deviceK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005
- Descendant · cites it directly · 36 of its ownK061090 Galileo Gold AsvHamilton Medical AG · 2006
- Descendant · 2 generations on · 26 of its ownK070513 Hamilton-G5Hamilton Medical AG · 2007 · Recalled
- Descendant · cites it directly · 23 of its ownK072412 Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor…Drager Medical AG & Co. Kgaa · 2008
- Descendant · 2 generations on · 21 of its ownK080181 Modification to Galileo GoldHamilton Medical AG · 2008
- Descendant · cites it directly · 16 of its ownK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008 · Recalled (Class I)
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 51 · See all- K061090Galileo Gold AsvHamilton Medical AG · 2006 · cites it directly36descendants
- K070513Hamilton-G5Hamilton Medical AG · 2007 · 2 generations on26descendants
- K072412Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Drager Medical AG & Co. Kgaa · 2008 · cites it directly23descendants
- K080181Modification to Galileo GoldHamilton Medical AG · 2008 · 2 generations on21descendants
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −5 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −4 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −3 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −2 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −1 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| 0 (this device) | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | — |
| +1 | K061090 | Galileo Gold Asv | Hamilton Medical AG | 2006 | — |
| +2 | K070513 | Hamilton-G5 | Hamilton Medical AG | 2007 | 1 |
| +1 | K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor… | Drager Medical AG & Co. Kgaa | 2008 | — |
| +2 | K080181 | Modification to Galileo Gold | Hamilton Medical AG | 2008 | — |
| +1 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
22 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? (7)
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 |
|---|---|---|---|
| * | K980642 | EVITA 4 (8411900)Summary page 2…lass: 2 K010093) Legally Marketed Device Identification: EvitaXL (K980642, K983219, K(992608, Device Description: Bas… | 1998 |
| * | K983219 | Neoflow Option Model Numbers 8413563, 8411900Summary page 2…2 K010093) Legally Marketed Device Identification: EvitaXL (K980642, K983219, K(992608, Device Description: Basic differ… | 1998 |
| * | K992608 | Atc Option for Evita 2 Dura and Evita 4Summary page 3…Drgtger Medical AG & Co. KGaA K(983219 Evita 4, Evita 2dura Drnger Medical AG & Co. KGaA K992608 Evita 4, Evita 2dura Drger Medical AG & Co. KGaA K010093 Ev… | 1999 |
| * | K010093 | Non-Invasive Ventilation Niv Option, Model 84 14 474Summary page 2…ion Number: 21 CFR 868.5895 Class: 2 K010093) Legally Marketed Device Identification: EvitaXL (K980642, K983219, K(992608, Device Description:… | 2001 |
| * | K040574 | Galileo GoldSummary page 3…Drger Medical AG & Co. KGaA K010093 Evita 4, Evita 2dura Drfger Medical AG & Co. KGaA K040574 Galileo Gold Hamilton Medical AG K970839 Servo'… | 2004 |
| * | K970839 | Servo Ventilator 300ASummary page 3…ta 2dura Drfger Medical AG & Co. KGaA K040574 Galileo Gold Hamilton Medical AG K970839 Servo' Maquet Critical Care AB K021573 840… | 1997 |
| * | K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus OptionSummary page 3…Gold Hamilton Medical AG K970839 Servo' Maquet Critical Care AB K021573 840 Tyco NPB Substantial Equivalence:… | 2002 |
What descends from it? (51)
See all 519 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061090 | Galileo Gold Asv | 2006 | 36 |
| K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models… | 2008 | 23 |
| K081521 | Modification to Hamilton-G5 Class I | 2008 | 16 |
| K093632 | Infinity Acute Care System Workstation Neonatal Care Class I | 2010 | 10 |
| K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software Option Class I | 2006 | 6 |
| K103578 | Philips NM3 Respiratory Monitor with Ventassist | 2011 | 4 |
| K061094 | Newport E500 Wave Ventilator | 2006 | 2 |
| K100941 | Infinity Mcable - Mainstream CO2 | 2010 | 1 |
| K062793 | Servo-I Ventilator System, Model 64 87 800 E407E; Nava Option | 2007 | 0 |
Has anything in its family been recalled? (22 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2008 | Not classified | Z-2327-2008 | Nonconforming Material/Component | audible power failure alarm was not enunciated at the required volume |
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.
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K053388Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionPuritan Bennett Corp. · 2006 · Cites it directly · ◆ in the 2006 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
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 generations on · ◆ in the 2011 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
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K103211Avea VentilatorCare Fusion · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 114 Class I recalls
Nearest 12 of 22 shown.
Nearest 5 of 22; all are on the web page.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 26 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K061090 (Hamilton Medical AG, 2006) has gone furthest, with 36 descendants of its own.
- 6 other devices also cite its predicate K980642.
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 EvitaXL is a long-term ventilator for intensive care for adults, children, and infants with a body weight of at least 3 kg (6.6 lbs). With SmartCare"/PS the EvitaXL is intended to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). The patients should be haemodynamicaily stable with adequate oxygenation and spontaneous breathing.…
Read the full statement (127 words)
The EvitaXL is a long-term ventilator for intensive care for adults, children, and infants with a body weight of at least 3 kg (6.6 lbs).
With SmartCare"/PS the EvitaXL is intended to stabilize the patient's spontaneous breathing in a "comfortable zone" and to reduce inspiratory support for adults and children with a body weight of at least 15 kg (33 lbs). The patients should be haemodynamicaily stable with adequate oxygenation and spontaneous breathing. SmartCare can be used for intubated or tracheotomized patients. Patients with body weight between 15 and 35 kg (33.1 and 77.8 lbs) must be endotracheally intubated and ventilated with active humidification.
SmartCarew/PS is contraindicated in case of severe COPD and severe neurologic disorder that effects the cerebral control mechanism of the spontaneous breathing pattern.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051263: Evitaxl with Option Smartcare.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051263
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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