510(k) · Cleared
Recalled · 2007GE 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 Jun 5, 2006 as substantially equivalent to K051895 (Datex-Ohmeda, Inc., 2005) after a 68-day review. Its family tree reaches back 5 generations to 1991. 20 of the 64 devices in its family, counting itself, have a Class I recall. 48 later devices descend from it. It has been recalled once.
- Decided
- Jun 5, 2006
- Review
- 68 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902859 (1991). 15 ancestors in all. 48 later devices descend from it, 1 citing it directly. 20 of the 64 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 4 generations backK961687 EVITA 4Drager, Inc. · 1996
- 3 generations backK970165 Evita 2 DuraDrager, Inc. · 1997
- 2 generations backK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- 1 generation backK051895 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005
- This deviceK060862 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006
- Descendant · cites it directly · 47 of its ownK062710 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 37 of its ownK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- Descendant · 3 generations on · 21 of its ownK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- Descendant · 2 generations on · 21 of its ownK080181 Modification to Galileo GoldHamilton Medical AG · 2008
- Descendant · 2 generations on · 16 of its ownK081521 Modification to Hamilton-G5Hamilton Medical AG · 2008 · Recalled (Class I)
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 48 · See all- K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · cites it directly47descendants
- K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008 · 2 generations on37descendants
- K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010 · 3 generations on21descendants
- K080181Modification to Galileo GoldHamilton Medical AG · 2008 · 2 generations on21descendants
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −4 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −3 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| −2 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| −1 | K051895 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2005 | — |
| 0 (this device) | K060862 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | — |
| +1 | K062710 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | 2 |
| +2 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| +3 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| +2 | K080181 | Modification to Galileo Gold | Hamilton Medical AG | 2008 | — |
| +2 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 3 | 1 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 5 | 4 |
| 2012 | 5 | 2 |
| 2013 | 6 | 3 |
| 2014 | 1 | 0 |
| 2015 | 5 | 1 |
| 2016 | 2 | 2 |
| 2017 | 4 | 2 |
| 2018 | 1 | 0 |
| 2019 | 3 | 1 |
| 2020 | 2 | 1 |
| 2021 | 3 | 1 |
| 2023 | 1 | 1 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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.
20 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? (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 |
|---|---|---|---|
| * | K051895 | GE Datex-Ohmeda Engstrom CarestationSummary page 1…y marketed device: GE Datex-Ohmeda Engstrom Carestation- Class LI - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log number KO051895. The Engstr~m Ventilator (EV) is a flexible, adaptable, and intuitive critical care ventilator. A wide selection of performance… | 2005 |
What descends from it? (48)
See all 481 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062710 | GE Datex-Ohmeda Engstrom Carestation | 2006 | 47 |
Has anything in its family been recalled? (20 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 2, 2007 | Not classified | Z-0784-2007 | Other | There are two unique conditions with the Engstrom Carestation that require corrective action. These include an anomaly in the control of the safety relief valve and a situation where the display unit may reset. |
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 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K130178Inspiration Ventilator System 5I/7IeVent Medical, Ltd. · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K131774Hamilton-G5Hamilton Medical AG · 2013 · 4 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
- K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900…Datex-Ohmeda, Inc. · 2017 · 5 generations on · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
Nearest 12 of 20 shown.
Nearest 5 of 20; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 5 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K062710 (Datex-Ohmeda, Inc., 2006) has gone furthest, with 47 descendants of its own.
- 1 other device also cites its predicate K051895.
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 Engstrbm 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 available include: * Volume Controlled (VCV) * Pressure Controlled (PCV) * Pressure Controlled, Volume Guaranteed (PCV-VG) * Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) * Synchronized…
Read the full statement (203 words)
The GE Datex-Ohmeda Engstrbm 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 available include:
* Volume Controlled (VCV)
* Pressure Controlled (PCV)
* Pressure Controlled, Volume Guaranteed (PCV-VG)
* 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 (CPAP/PSV)
* Apnea backup (active in Bi-level and CPAP/PSV)
The GE Datex-Ohmeda Engstr6m 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 in the product labeling, an integrated air compressor, capabilities to measure SpiroDynamics via an intratracheal pressure sensor in patients using sized 6.5 tracheal tubes and larger, and calculation of functional residual capacity of mechanically ventilated patients using Nitrogen Wash In/ash Out method.
The Engstrbm Carestation is not a pulmonary function calculation device.
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/K060862 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060862: GE Datex-Ohmeda Engstrom Carestation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060862
Report an extraction error
Are you the manufacturer?
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