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 Oct 26, 2004 as substantially equivalent to K992608 (Drager, Inc., 1999) and 2 other predicates after a 117-day review. Its family tree reaches back 3 generations to 1991. 37 of the 119 devices in its family, counting itself, have a Class I recall. 107 later devices descend from it.
- Decided
- Oct 26, 2004
- Review
- 117 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K902859 (1991). 11 ancestors in all. 107 later devices descend from it, 4 citing it directly. 37 of the 119 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 2 generations backK961687 EVITA 4Drager, Inc. · 1996
- 1 generation backK970165 Evita 2 DuraDrager, Inc. · 1997
- This deviceK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- Descendant · cites it directly · 57 of its ownK051767 LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005
- Descendant · cites it directly · 49 of its ownK051895 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005
- Descendant · 2 generations on · 48 of its ownK060862 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 47 of its ownK062710 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 37 of its ownK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
Showing 5 of 107 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 107 · See all- K051767LTV 1000 VentilatorPulmonetic Systems, Inc. · 2005 · cites it directly57descendants
- K051895GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2005 · cites it directly49descendants
- K060862GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · 2 generations on48descendants
- K062710GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2006 · 2 generations on47descendants
- K081842Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008 · 3 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −2 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −1 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| 0 (this device) | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| +1 | K051767 | LTV 1000 Ventilator | Pulmonetic Systems, Inc. | 2005 | — |
| +1 | K051895 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2005 | — |
| +2 | K060862 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | 1 |
| +2 | K062710 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2006 | 2 |
| +3 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 2 |
| 2008 | 5 | 1 |
| 2009 | 6 | 2 |
| 2010 | 6 | 1 |
| 2011 | 11 | 6 |
| 2012 | 12 | 4 |
| 2013 | 9 | 4 |
| 2014 | 4 | 0 |
| 2015 | 6 | 1 |
| 2016 | 7 | 3 |
| 2017 | 6 | 4 |
| 2018 | 2 | 1 |
| 2019 | 6 | 3 |
| 2020 | 2 | 1 |
| 2021 | 5 | 2 |
| 2023 | 1 | 1 |
| 2024 | 5 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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.
37 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? (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 |
|---|---|---|---|
| * | K992608 | Atc Option for Evita 2 Dura and Evita 4Summary page 1…following currently marketed device: Drager Evita 4- Class II - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log number K992608. Drager Evita 2- Class II - 21 CFR868.5895, which has been the subject of a cleared 510(k) with FDA log nu… | 1999 |
| * | K970165 | Evita 2 DuraSummary page 1…with FDA log number K992608. Drager Evita 2- Class II - 21 CFR868.5895, which has been the subject of a cleared 510(k) with FDA log number K970165. Datex-Obmeda 7900 Ventilator -Class H - 21CFR868.5895, which has been the subject of several cleared 5 10… | 1997 |
| * | K023366 | Datex-Ohmeda 7900 Ventilator EnhancementsSummary page 1…. Datex-Obmeda 7900 Ventilator -Class H - 21CFR868.5895, which has been the subject of several cleared 5 10(k)s, most recently with FDA log number K023366 The Engstrdm Ventilator (EV) is a critical care ventilator that is flexible and physically adaptable to a variety of work env… | 2003 |
What descends from it? (107)
See all 1074 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (37 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 · Direct predicate · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K090888Newport HT70 Family of VentilatorsNewport Medical Instruments, Inc. · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 15 Class I recalls
- K070899Puritan Bennett Legendair XL2Nellcor Puritan Bennett · 2007 · 2 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 12 Class I recalls
- K111146Newport HT70 VentilatorNewport Medical Instruments, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 14 Class I recalls
- K081521Modification to Hamilton-G5Hamilton Medical AG · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 14 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 114 Class I recalls
- K162832731 Series VentilatorsZOLL Medical Corporation · 2017 · 4 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K103803Hamilton-G5Hamilton Medical AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
Nearest 12 of 37 shown.
Nearest 5 of 37; all are on the web page.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 4 of the 11 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K051767 (Pulmonetic Systems, Inc., 2005) has gone furthest, with 57 descendants of its own.
- 4 other devices also cite its predicate K992608.
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-VG) · Synchronized Intermittent Mandatory Ventilation, Volume Controlled (SIMV-VC) • Synchronized…
Read the full statement (146 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-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 Engstrom Carestation includes integrated Oxygen, FiO2, airway pressure, spirometry and volume monitoring and an integrated Aerogen Aeroneb Pro nebulizer. Options include integrated respiratory gas monitoring capabilities via various Datex-Ohmeda patient monitoring modules listed in the product labeling.
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/K041775 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041775: GE Datex-Ohmeda Engstrom Carestation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041775
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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