510(k) · Cleared
Recalled · Class I · 2022Infinity Acute Care System Workstation Critical Care
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Draegerwerk AG & CO Kgaa · CBK Ventilator, Continuous, Facility Use
Cleared on Mar 30, 2010 after a 127-day review. The FDA summary names no predicate by number. 3 of the 13 devices in its family, counting itself, have a Class I recall. 12 later devices descend from it. It has been recalled 6 times, including 4 Class I recalls.
- Decided
- Mar 30, 2010
- Review
- 127 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 6 (4 Class I)
- Predicates
- 0
12 later devices descend from it, 5 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.
- This deviceK093633 Infinity Acute Care System Workstation Critical CareDraegerwerk AG & CO Kgaa · 2010
- Descendant · cites it directly · 4 of its ownK181695 Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 3 of its ownK192307 Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2020 · Recalled
- Descendant · cites it directly · 2 of its ownK133886 Perseus A500Draeger Medical GmbH · 2014 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK230931 AtlanDrägerwerk AG Co. Kgaa · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 1 of its ownK222644 Nihon Kohden NKV-440 Ventilator SystemNihon Kohden Orangemed, Inc. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 12 · See all- K181695Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2018 · cites it directly4descendants
- K192307Nihon Kohden NKV-550 Series Ventilator SystemNihon Kohden Orangemed, Inc. · 2020 · 2 generations on3descendants
- K133886Perseus A500Draeger Medical GmbH · 2014 · cites it directly2descendants
- K230931AtlanDrägerwerk AG Co. Kgaa · 2023 · 2 generations on1descendant
- K222644Nihon Kohden NKV-440 Ventilator SystemNihon Kohden Orangemed, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093633 | Infinity Acute Care System Workstation Critical Care | Draegerwerk AG & CO Kgaa | 2010 | — |
| +1 | K181695 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2018 | 1 |
| +2 | K192307 | Nihon Kohden NKV-550 Series Ventilator System | Nihon Kohden Orangemed, Inc. | 2020 | 1 |
| +1 | K133886 | Perseus A500 | Draeger Medical GmbH | 2014 | Class I |
| +2 | K230931 | Atlan | Drägerwerk AG Co. Kgaa | 2023 | Class I |
| +3 | K222644 | Nihon Kohden NKV-440 Ventilator System | Nihon Kohden Orangemed, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 1 | 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.
3 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?
The FDA summary names no predicate by number.
What descends from it? (12)
See all 125 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2022 | Class II | Z-0870-2022 | Nonconforming Material/Component | Cybersecurity Improvement Action-not equipped against potential cyber security threats |
| Sep 10, 2021 | Class II | Z-0108-2022 | Software design | Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds |
| Feb 4, 2016 | Class I | Z-0827-2016 | Software design | The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in… |
| Dec 1, 2015 | Class I | Z-0436-2016 | Software design | The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm… |
| Jul 13, 2015 | Class I | Z-2343-2015 | Nonconforming Material/Component | The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. |
| Feb 7, 2014 | Class I | Z-1298-2014 | Component design/selection | The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected. |
The 5 latest of 6 recalls; the web page lists all.
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.
What does this lineage say?
- Of its descendants, K181695 (Nihon Kohden Orangemed, Inc., 2018) has gone furthest, with 4 descendants of its own.
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 Infinity Acute Care System Workstations Critical Care consist of monitoring and control displays and additional therapy units. They are intended to be used as integrated, networked, and configurable workstations to provide critical care specific therapy. The Infinity Acute Care System Workstations Critical Care are intended to be used by qualified and trained medical personnel. The Infinity C Series Medical Cockpits, consisting of the C500 and the…
Read the full statement (206 words)
The Infinity Acute Care System Workstations Critical Care consist of monitoring and control displays and additional therapy units. They are intended to be used as integrated, networked, and configurable workstations to provide critical care specific therapy. The Infinity Acute Care System Workstations Critical Care are intended to be used by qualified and trained medical personnel.
The Infinity C Series Medical Cockpits, consisting of the C500 and the C700, are monitoring and control displays for the Infinity Acute Care System (IACS). Medical Cockpits are intended to be used to monitor waveforms, parameter information, and alarms as well as to control settings. The Infinity Series Medical Cockpits are intended to be used in environments where patient care is provided by trained healthcare professionals.
The Evita V500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of adult, pediatric and neonatal patients. Evita V500 offers mandatory ventilation modes and ventilation modes for spontaneous breathing support and airway monitoring. The Evita V500 ventilation unit is used with Infinity C Series Dr~ger Medical Cockpits. The Evita V500 ventilation unit is intended for use in different medical care areas.
Evita V500 is intended for stationary use in hospitals and medical rooms or for patient transportation within the hospital.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093633: Infinity Acute Care System Workstation Critical Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093633
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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