510(k) · Cleared
ClearedEngstrom Carestation, Engstrom Pro
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 Feb 3, 2015 as substantially equivalent to K111116 (Datex-Ohmeda, 2011) after a 334-day review. Its family tree reaches back 13 generations to 1991. 8 of the 86 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 3, 2015
- Review
- 334 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K902859 (1991). 85 ancestors in all, the oldest K883038 (1988). No later device cites it as a predicate yet. 8 of the 86 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 9 generations between
- 3 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 2 generations backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- 1 generation backK111116 Engstrom Carestation, Engstrom Pro, Models 1505-9000-000…Datex-Ohmeda · 2011 · Recalled (Class I)
- This deviceK140575 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2015
Show all 13 generations
- Root · 13 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 12 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 11 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 10 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 9 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 8 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 7 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 6 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 5 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 4 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 3 generations backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- 2 generations backK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- 1 generation backK111116 Engstrom Carestation, Engstrom Pro, Models 1505-9000-000…Datex-Ohmeda · 2011 · Recalled (Class I)
- This deviceK140575 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2015
Class I recalls in this family
- K111116 Engstrom Carestation, Engstrom Pro, Models…direct predicate · 2011
- K041223 Modification to Servo-I Ventilator System, Model…3 generations back · 2004
- K001646 Puritan-Bennett 840 Ventilator System with…5 generations back · 2000
- K984535 Puritan-Bennett 840 Ventilatory System with…5 generations back · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −12 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −11 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −10 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −9 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −8 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −7 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −6 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −5 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −4 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −3 | 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 | K111116 | Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000 | Datex-Ohmeda | 2011 | Class I |
| 0 (this device) | K140575 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 5 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 3 |
| 1999 | 6 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 1 |
| 2004 | 6 | 1 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2007 | 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.
8 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 |
|---|---|---|---|
| * | K111116 | Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Summary page 5…ADE as required by 807.92(a)(3) The Engström Ventilator is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Engström Ventilator (K111116). DEVICE DESCRIPTION as required by 807.92(a)(4) The GE Datex-Ohmeda Engström Carestation and Engström Pro are flexible, adapt… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (8 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.
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · 3 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 5 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 7 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 7 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 24 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 28 of the 85 ancestors have a recall of any class; 8 have a Class I recall.
- 1 other device also cites its predicate K111116.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Engström Carestation and Engström Pro are 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 on Engström Carestation and Engström Pro expand the patient range to 0.25 kg. The GE Datex-Ohmeda Engström Carestation and Engström Pro are microprocessor based, electronically controlled, pneumatically…
Read the full statement (186 words)
The GE Datex-Ohmeda Engström Carestation and Engström Pro are 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 on Engström
Carestation and Engström Pro expand the patient range to 0.25 kg.
The GE Datex-Ohmeda Engström Carestation and Engström Pro are microprocessor based,
electronically controlled, pneumatically driven ventilators that include integrated FiO2, airway
pressure, spirometry, and volume monitoring. Options include an Aerogen Aeroneb nebulizer,
data capture accessory and an integrated air compressor. Options available on Engström
Carestation only include integrated respiratory gas monitoring capabilities via various Datex-
Ohmeda patient monitoring modules listed in the product labeling, 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 Engström 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/K140575 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140575: Engstrom Carestation, Engstrom Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140575
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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