510(k) · Cleared
ClearedGE Datex-Ohmeda Centiva/5 Ventilator
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 21, 2005 as substantially equivalent to K992608 (Drager, Inc., 1999) and 2 other predicates after a 77-day review. Its family tree reaches back 4 generations to 1991. 1 of the 13 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 21, 2005
- Review
- 77 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K902859 (1991). 12 ancestors in all. No later device cites it as a predicate yet. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 3 generations backK961687 EVITA 4Drager, Inc. · 1996
- 2 generations backK970165 Evita 2 DuraDrager, Inc. · 1997
- 1 generation backK041775 GE Datex-Ohmeda Engstrom CarestationDatex-Ohmeda, Inc. · 2004
- This deviceK050860 GE Datex-Ohmeda Centiva/5 VentilatorDatex-Ohmeda, Inc. · 2005
Class I recalls in this family
- K023366 Datex-Ohmeda 7900 Ventilator Enhancements2 generations back · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −3 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −2 | K970165 | Evita 2 Dura | Drager, Inc. | 1997 | — |
| −1 | K041775 | GE Datex-Ohmeda Engstrom Carestation | Datex-Ohmeda, Inc. | 2004 | — |
| 0 (this device) | K050860 | GE Datex-Ohmeda Centiva/5 Ventilator | Datex-Ohmeda, Inc. | 2005 | — |
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 |
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.
1 device in this family has 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 1I - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log number K992608. Drager Evita 2- Class II - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log nu… | 1999 |
| * | K970165 | Evita 2 DuraSummary page 1…with FDA log number K992608. Drager Evita 2- Class II - 21CFR868.5895, which has been the subject of a cleared 5 10(k) with FDA log number K970165. GE Datex-Ohmeda Engstrom Carestation -Class IL- 21CFR868.5895, which has been the subject of several clea… | 1997 |
| * | K041775 | GE Datex-Ohmeda Engstrom CarestationSummary page 1…GE Datex-Ohmeda Engstrom Carestation -Class IL- 21CFR868.5895, which has been the subject of several cleared 51 0(k)s, most recently with FDA log number K041775. The Centiva/5 is a flexible, intuitive and simple to operate critical care ventilator. It offers a configurable and compact… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 4 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- 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 Centiva/5 Critical Care Ventilator is designed as a critical care ventilator for adult to pediatric patients. It provides volume control, pressure volume, bi-level and pressure support ventilation (PSV), Continuous Positive Pressure (CPAP) and PSV with apnea back-up ventilation modes. It incorporates integrated airway pressure, patient flow, tidal volume, minute volume, peak pressure, PEEP, rate and FlO2 monitoring.
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/K050860 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050860: GE Datex-Ohmeda Centiva/5 Ventilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050860
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