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., A Division of Instrumentarium C · CBK Ventilator, Continuous, Facility Use
Cleared on May 3, 2010 as substantially equivalent to K081842 (Datex-Ohmeda, Inc., 2008) and 3 other predicates after a 136-day review. Its family tree reaches back 11 generations to 1991. 14 of the 97 devices in its family, counting itself, have a Class I recall. 21 later devices descend from it.
- Decided
- May 3, 2010
- Review
- 136 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K902859 (1991). 75 ancestors in all, the oldest K883038 (1988). 21 later devices descend from it, 3 citing it directly. 14 of the 97 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations between
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 1 generation backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- This deviceK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
- Descendant · cites it directly · 13 of its ownK112722 GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 11 of its ownK123125 GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · Recalled (Class I)
- Descendant · cites it directly · 9 of its ownK110213 GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK142552 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015
- Descendant · 3 generations on · 4 of its ownK151954 A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · Recalled
Show all 11 generations
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 9 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 8 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 7 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 6 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 5 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 4 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK063404 Servo-I Ventilator System, Models 64, 87 and 800Maquet Critical Care AB · 2007
- 1 generation backK081842 Engstrom Carestation, Engstrom ProDatex-Ohmeda, Inc. · 2008
- This deviceK093886 Engstrom Carestation, Engstrom ProDatex-Ohmeda Inc., A Division of Instrumentarium C · 2010
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 21 · See all- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · cites it directly13descendants
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 2 generations on11descendants
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · cites it directly9descendants
- K142552A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 2 generations on5descendants
- K151954A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −10 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −9 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −8 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −7 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −6 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −5 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −2 | K063404 | Servo-I Ventilator System, Models 64, 87 and 800 | Maquet Critical Care AB | 2007 | — |
| −1 | K081842 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda, Inc. | 2008 | — |
| 0 (this device) | K093886 | Engstrom Carestation, Engstrom Pro | Datex-Ohmeda Inc., A Division of Instrumentarium C | 2010 | — |
| +1 | K112722 | GE Datex-Ohmeda Avance | Datex-Ohmeda, Inc. | 2011 | Class I |
| +2 | K123125 | GE Datex-Ohmeda Avance CS2 | Datex-Ohmeda, Inc. | 2013 | Class I |
| +1 | K110213 | GE Datex-Ohmeda Aisys | Datex-Ohmeda, Inc. | 2011 | Class I |
| +2 | K142552 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | — |
| +3 | K151954 | A7 Anesthesia System | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015 | 3 |
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 | 9 | 2 |
| 1999 | 6 | 0 |
| 2000 | 3 | 1 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 1 |
| 2004 | 5 | 1 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 3 |
| 2013 | 4 | 1 |
| 2014 | 1 | 0 |
| 2015 | 4 | 1 |
| 2016 | 1 | 1 |
| 2017 | 2 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 1 |
| 2026 | 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.
14 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? (4)
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 |
|---|---|---|---|
| * | K081842 | Engstrom Carestation, Engstrom ProSummary page 1…as required by 807.92(a)H3) The Engstrom Ventilator is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Engstrom (K081842), Maquet Servo-i (K063404, K041 223) and Drager BabyL-og 8000 Plus (K974176).… | 2008 |
| * | K063404 | Servo-I Ventilator System, Models 64, 87 and 800Summary page 1…) The Engstrom Ventilator is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Engstrom (K081842), Maquet Servo-i (K063404, K041 223) and Drager BabyL-og 8000 Plus (K974176). 17 === Page… | 2007 |
| * | K041223 | Modification to Servo-I Ventilator System, Model 64 87 800 E407ESummary page 1…The Engstrom Ventilator is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Engstrom (K081842), Maquet Servo-i (K063404, K041 223) and Drager BabyL-og 8000 Plus (K974176). 17 DEVI… | 2004 |
| * | K974176 | Babylog 8000 PlusSummary page 1…ent in safety and effectiveness to the legally marketed (predicate) Engstrom (K081842), Maquet Servo-i (K063404, K041 223) and Drager BabyL-og 8000 Plus (K974176). 17 DEVICE DESCRIPTION as required by 807.92(a)(4) The G… | 1998 |
What descends from it? (21)
See all 213 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (14 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.
- K041223Modification to Servo-I Ventilator System, Model 64 87 800 E407EMaquet Critical Care AB · 2004 · Direct predicate · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 5 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 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
- K111116Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000Datex-Ohmeda · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K112722GE Datex-Ohmeda AvanceDatex-Ohmeda, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K110213GE Datex-Ohmeda AisysDatex-Ohmeda, Inc. · 2011 · Cites it directly · ◆ in the 2011 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 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 110 Class I recalls
- K142679Carescape R860Datex-Ohmeda, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 13 Class I recalls
- K123125GE Datex-Ohmeda Avance CS2Datex-Ohmeda, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
Nearest 12 of 14 shown.
Nearest 5 of 14; all are on the web page.
What does this lineage say?
- The line of descent spans 19 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 23 of the 75 ancestors have a recall of any class; 6 have a Class I recall.
- Of its descendants, K112722 (Datex-Ohmeda, Inc., 2011) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K081842.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Engstrøm family of ventilators (Engstrøm Carestation and Engstrøm 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 Engstrøm family expand the patient range to 0.25 kg. The GE Datex-Ohmeda Engstrøm family of ventilators are microprocessor based, electronically controlled…
Read the full statement (185 words)
The GE Datex-Ohmeda Engstrøm family of ventilators (Engstrøm Carestation and Engstrøm 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 Engstrøm family expand the patient range to 0.25 kg.
The GE Datex-Ohmeda Engstrøm family of ventilators 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 Engstrøm 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 Engstrøm 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/K093886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093886: Engstrom Carestation, Engstrom Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093886
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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