510(k) · Cleared
Recalled · 2008GE 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 Dec 8, 2006 as substantially equivalent to K051895 (Datex-Ohmeda, Inc., 2005) and 3 other predicates after an 88-day review. Its family tree reaches back 6 generations to 1991. 20 of the 69 devices in its family, counting itself, have a Class I recall. 47 later devices descend from it. It has been recalled 2 times.
- Decided
- Dec 8, 2006
- Review
- 88 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 6 generations to K902859 (1991). 21 ancestors in all. 47 later devices descend from it, 3 citing it directly. 20 of the 69 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 backK970165 Evita 2 DuraDrager, Inc. · 1997
- 3 generations backK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- 2 generations backK051895 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005
- 1 generation backK060862 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
- This deviceK062710 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006
- Descendant · cites it directly · 37 of its ownK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- Descendant · 2 generations on · 21 of its ownK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- Descendant · cites it directly · 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)
- Descendant · 2 generations on · 14 of its ownK103803 Hamilton-G5Hamilton Medical AG · 2011 · Recalled (Class I)
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 47 · See all- K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008 · cites it directly37descendants
- K093886Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010 · 2 generations on21descendants
- K080181Modification to Galileo GoldHamilton Medical AG · 2008 · cites it directly21descendants
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · cites it directly16descendants
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 generations on14descendants
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 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| −3 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| −2 | K051895 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2005 | — |
| −1 | K060862 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | 1 |
| 0 (this device) | K062710 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | — |
| +1 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| +2 | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| +1 | K080181 | Modification to Galileo Gold | Hamilton Medical AG | 2008 | — |
| +1 | K081521 | Modification to Hamilton-G5 | Hamilton Medical AG | 2008 | Class I |
| +2 | K103803 | Hamilton-G5 | Hamilton Medical AG | 2011 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051895 | GE Datex-Ohmeda Engstrom CarestationSummary page 1…ently marketed device: GE Datex-Ohmeda Engstrom Carestation- Class II - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log number K051895, and K060862. Drager Evita XL - Class II - 21CFRB6X.5895, which has been the subject of a cleared 5 10(k) with FDA… | 2005 |
| * | K060862 | GE Datex-Ohmeda Engstrom CarestationSummary page 1…d device: GE Datex-Ohmeda Engstrom Carestation- Class II - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log number K051895, and K060862. Drager Evita XL - Class II - 21CFRB6X.5895, which has been the subject of a cleared 5 10(k) with FDA log number K0… | 2006 |
| Kept off the family tree | K051623 | FDA’s K051623 is Anatomical Shoulder Keeled Glenoid Our reading of the summary gave K051623, FDA’s number for Anatomical Shoulder Keeled Glenoid (Zimmer GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “Drager Evita XL”. Kept off the family tree. Summary page 1…) with FDA log number K051895, and K060862. Drager Evita XL - Class II - 21CFRB6X.5895, which has been the subject of a cleared 5 10(k) with FDA log number K05 1623 Drager Babylog 8000 Plus - Class II - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log n… | 2005 |
| * | K974176 | Babylog 8000 PlusSummary page 1…10(k) with FDA log number K05 1623 Drager Babylog 8000 Plus - Class II - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log number K974176 Siemens Servo-I - Class It - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log number K04… | 1998 |
| * | K041122 | Precision Liquid Oxygen System | 2004 |
What descends from it? (47)
See all 473 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (20 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2008 | Not classified | Z-1829-2008 | Device Design | There is a correction associated with Engstrom Carestation with an integrated Aerogen Professional Nebulizer System. There is an issue relating to the removal of the nebulizer cable from nebulizer connection port, which, when done while… |
| Jul 2, 2007 | Not classified | Z-1526-2008 | Nonconforming Material/Component | Neonatal Flow Sensors supplied for use with the Neonatal Enhancement for the Engstrm Carestation may result in the sensors providing invalid values and alarm messages when exposed to high flow rates. |
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 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 2 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 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K121225Hamilton-C2Hamilton Medical AG · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- 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
- K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900…Datex-Ohmeda, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 4 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K120670Hamilton-T1Hamilton Medical AG · 2012 · 4 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.
- 8 of the 21 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K081842 (Datex-Ohmeda, Inc., 2008) has gone furthest, with 37 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 Engstr6m 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. Optional Neonatal capabilities expand the patient range to 0.5 kg. The modes of ventilation available include: * Volume Controlled (VCV) * Pressure Controlled (PCV) * Pressure Controlled, Volume Guaranteed (PCV-VG) * Synchronized Intermittent Mandatory…
Read the full statement (229 words)
The GE Datex-Ohmeda Engstr6m 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. Optional Neonatal capabilities expand the patient range to 0.5 kg. 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)
Synchronized Intermittent Mandatory Ventilation, Pressure Controlled Volume Guarantee (SIMV-PCVG)
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/Wash Out method.
Not all features are available with all patient populations.
The Engstr6m 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/K062710 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062710: 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/K062710
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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