510(k) · Cleared
ClearedGE Datex-Ohmeda Engstrom Carestation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda, Inc. · CBK Ventilator, Continuous, Facility Use
Cleared on Mar 25, 2005 as substantially equivalent to K041775 (Datex-Ohmeda, Inc., 2004) and 1 other predicate after a 16-day review. Its family tree reaches back 4 generations to 1991. 1 of the 15 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 25, 2005
- Review
- 16 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K902859 (1991). 14 ancestors in all. No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 3 generations backK961687 EVITA 4Drager, Inc. · 1996
- 2 generations backK970165 Evita 2 DuraDrager, Inc. · 1997
- 1 generation backK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- This deviceK050597 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005
Class I recalls in this family
- K023366 Datex-Ohmeda 7900 Ventilator Enhancements2 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −3 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −2 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| −1 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| 0 (this device) | K050597 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 1 |
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? (2)
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 |
|---|---|---|---|
| * | K041775 | GE Datex-Ohmeda Engstrom CarestationSummary page 1…rketed device: GE Datex-Ohmeda Engstrom Carestation- Class II - 21 CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K041775. Siemens Mini C Compressor -Class l- 21CFR 868.6250, which has been the subject of a cleared 510(k) with F… | 2004 |
| * | K023354 | Compressor Mini, 115 V, Model 64 81 779 EH81ESummary page 1…ith FDA log number K041775. Siemens Mini C Compressor -Class l- 21CFR 868.6250, which has been the subject of a cleared 510(k) with FDK log number K023354 The Engstrbm Ventilator (EV) is a flexible, adaptable, and intuitive critical care ventilator. A wide selection of performance o… | 2003 |
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.
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 5 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K041775.
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 GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. The modes of ventilation are available include: • Volume Controlled (VCV) * Pressure Controlled (PCV) * Pressure Controlled, Volume Guaranteed (PCV.M/G) * Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) Synchronized…
Read the full statement (156 words)
The GE Datex-Ohmeda Engstrom Carestation is designed to provide mechanical ventilation for adults and pediatrics weighing 5kg and above having degrees of pulmonary impairment varying from minor to severe. The modes of ventilation are available include:
• Volume Controlled (VCV)
* Pressure Controlled (PCV)
* Pressure Controlled, Volume Guaranteed (PCV.M/G)
* Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC)
Synchronized Intermittent Mandatory Ventilation, Pressure Controlled (SIMV-PC)
*Bi-level Airway Pressure Ventilation
Constant Positive Airway Pressure/Pressure Support Ventilation (CPAPLPSV)
Apnea backup (active in Bi-level and CPAP/PSV)
The GE Datex-Ohmeda Engstrom Carestation is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated FiO2, airway pressure, spirometry and volume monitoring and an Aerogen Aeroneb Pro nebulzier. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed inthe product labeling and an integrated air compressor.
The system is designed for facility use, including within-facility transport, and should only be used under the orders of a clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050597: GE Datex-Ohmeda Engstrom Carestation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050597
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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