510(k) · Cleared
Recalled · Class I · 2022Infinity Acute Care System Workstation Neonatal Care
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Drager Medical AG & Co. Kgaa · CBK Ventilator, Continuous, Facility Use
Cleared on Apr 5, 2010 as substantially equivalent to K903089 (Drager, Inc., 1991) and 9 other predicates after a 133-day review. Its family tree reaches back 8 generations to 1991. 9 of the 42 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 6 times, including 4 Class I recalls.
- Decided
- Apr 5, 2010
- Review
- 133 days
- Class
- Class II
- Product code
- CBK
- Recalls
- 6 (4 Class I)
- Predicates
- 10
Its longest line of descent runs back 8 generations to K902859 (1991). 31 ancestors in all, the oldest K902506 (1991). 10 later devices descend from it, 2 citing it directly. 9 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations backK961687 EVITA 4Drager, Inc. · 1996
- 6 generations backK970460 Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · Recalled (Class I)
- 5 generations backK984535 Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · Recalled (Class I)
- 4 generations backK022679 RaphaelHamilton Medical AG · 2003 · Recalled
- 3 generations backK040574 Galileo GoldHamilton Medical, Inc. · 2004
- 2 generations backK051263 Evitaxl with Option SmartcareDrager Medical AG & Co. Kgaa · 2005 · Recalled
- 1 generation backK072412 Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor…Drager Medical AG & Co. Kgaa · 2008
- This deviceK093632 Infinity Acute Care System Workstation Neonatal CareDrager Medical AG & Co. Kgaa · 2010
- Descendant · cites it directly · 8 of its ownK121225 Hamilton-C2Hamilton Medical AG · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK123637 Hamilton-C3Hamilton Medical AG · 2012
- Descendant · 3 generations on · 3 of its ownK161450 Hamilton-C3Hamilton Medical AG · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK140939 Hamilton-T1,Hamilton-C1Hamilton Medical AG · 2015 · Recalled
- Descendant · 4 generations on · 1 of its ownK201658 Hamilton-C6Hamilton Medical AG · 2020 · Recalled (Class I)
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K121225Hamilton-C2Hamilton Medical AG · 2012 · cites it directly8descendants
- K123637Hamilton-C3Hamilton Medical AG · 2012 · 2 generations on4descendants
- K161450Hamilton-C3Hamilton Medical AG · 2017 · 3 generations on3descendants
- K140939Hamilton-T1,Hamilton-C1Hamilton Medical AG · 2015 · 2 generations on2descendants
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −7 | K961687 | EVITA 4 | Drager, Inc. | 1996 | — |
| −6 | K970460 | Nellcor Puritan Bennett, 840 Ventilator System (Model 840) | Puritan Bennett Corp. | 1998 | Class I |
| −5 | K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel Option | Puritan Bennett Corp. | 1998 | Class I |
| −4 | K022679 | Raphael | Hamilton Medical AG | 2003 | 3 |
| −3 | K040574 | Galileo Gold | Hamilton Medical, Inc. | 2004 | — |
| −2 | K051263 | Evitaxl with Option Smartcare | Drager Medical AG & Co. Kgaa | 2005 | 1 |
| −1 | K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor… | Drager Medical AG & Co. Kgaa | 2008 | — |
| 0 (this device) | K093632 | Infinity Acute Care System Workstation Neonatal Care | Drager Medical AG & Co. Kgaa | 2010 | — |
| +1 | K121225 | Hamilton-C2 | Hamilton Medical AG | 2012 | Class I |
| +2 | K123637 | Hamilton-C3 | Hamilton Medical AG | 2012 | — |
| +3 | K161450 | Hamilton-C3 | Hamilton Medical AG | 2017 | 2 |
| +2 | K140939 | Hamilton-T1,Hamilton-C1 | Hamilton Medical AG | 2015 | 1 |
| +4 | K201658 | Hamilton-C6 | Hamilton Medical AG | 2020 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 1 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 1 |
| 2015 | 1 | 0 |
| 2016 | 1 | 1 |
| 2017 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 1 | 1 |
| 2021 | 1 | 1 |
| 2023 | 1 | 0 |
| 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.
9 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? (10)
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 |
|---|---|---|---|
| * | K903089 | Babylog 8000 Infant VentilatorSummary page 2…diatric patients. Legally Marketed Device to which Substantial Equivalence is claimed: 510(k) number Trade name _ Company K903089, Babylog 8000 plus Dr~ger Medical AG & Co. KG K926292, K9741 76 K961687,… | 1991 |
| * | K926292 | Babylog 8000 Infant VentilatorSummary page 2…mber Trade name _ Company K903089, Babylog 8000 plus Dr~ger Medical AG & Co. KG K926292, K9741 76 K961687, Evita XIL Dr~ger Medical AG & Co. KG K9832 19, K980642 K9… | 1994 |
| * | K974176 | Babylog 8000 PlusSummary page 2…Trade name _ Company K903089, Babylog 8000 plus Dr~ger Medical AG & Co. KG K926292, K9741 76 K961687, Evita XIL Dr~ger Medical AG & Co. KG K9832 19, K980642 K992608, KOI… | 1998 |
| * | K961687 | EVITA 4Summary page 2…de name _ Company K903089, Babylog 8000 plus Dr~ger Medical AG & Co. KG K926292, K9741 76 K961687, Evita XIL Dr~ger Medical AG & Co. KG K9832 19, K980642 K992608, KOI10093, K… | 1996 |
| * | K983219 | Neoflow Option Model Numbers 8413563, 8411900Summary page 2…Dr~ger Medical AG & Co. KG K926292, K9741 76 K961687, Evita XIL Dr~ger Medical AG & Co. KG K9832 19, K980642 K992608, KOI10093, KO0i1263, K072412 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _… | 1998 |
| * | K980642 | EVITA 4 (8411900)Summary page 2…Dr~ger Medical AG & Co. KG K926292, K9741 76 K961687, Evita XIL Dr~ger Medical AG & Co. KG K9832 19, K980642 K992608, KOI10093, KO0i1263, K072412 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _… | 1998 |
| * | K992608 | Atc Option for Evita 2 Dura and Evita 4Summary page 2…Dr~ger Medical AG & Co. KG K926292, K9741 76 K961687, Evita XIL Dr~ger Medical AG & Co. KG K9832 19, K980642 K992608, KOI10093, KO0i1263, K072412 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _… | 1999 |
| * | K010093 | Non-Invasive Ventilation Niv Option, Model 84 14 474 | 2001 |
| * | K051263 | Evitaxl with Option Smartcare Our reading of the summary gave K011263, which is not a number in FDA’s lists. Corrected to the only number one digit away that is an earlier device of this one’s maker, Drager Medical AG & Co. Kgaa, in this field. | 2005 |
| * | K072412 | Option Smartcare for Evitaxl,Smartcare Kit Capno Package, CO2 Sensor Capnosmart, Models…Summary page 2…o. KG K926292, K9741 76 K961687, Evita XIL Dr~ger Medical AG & Co. KG K9832 19, K980642 K992608, KOI10093, KO0i1263, K072412 _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _… | 2008 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (9 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 14, 2022 | Class II | Z-0871-2022 | Nonconforming Material/Component | Cybersecurity Improvement Action-not equipped against potential cyber security threats |
| Sep 10, 2021 | Class II | Z-0109-2022 | 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.
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K984535Puritan-Bennett 840 Ventilatory System with Bilevel OptionPuritan Bennett Corp. · 1998 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K121225Hamilton-C2Hamilton Medical AG · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K181216Hamilton-T1, Hamilton-C1Hamilton Medical AG · 2019 · 3 generations on · ◆ in the 2019 descendants bar of FIG. 15 Class I recalls
- K153046Hamilton-MR1Hamilton Medical AG · 2016 · 3 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K201306Hamilton-C3Hamilton Medical AG · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K201658Hamilton-C6Hamilton Medical AG · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 19 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 11 of the 31 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K121225 (Hamilton Medical AG, 2012) has gone furthest, with 8 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 Neonatal 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 specific therapy in neonatal intensive care. The Infinity Acute Care System Workstations Neonatal Care are intended to be used by qualified and trained medical personnel. The Infinity C Series Medical Cockpits, consisting of the…
Read the full statement (229 words)
The Infinity Acute Care System Workstations Neonatal 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 specific therapy in neonatal intensive care. The Infinity Acute Care System Workstations Neonatal 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 waveformis, 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 Babylog VN500 ventilation unit of the Infinity Acute Care System is intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (I I lbs) up to 20 kg (44 Ibs) bodyweight. lBabylog VN500 offers mandatory ventilation modes for spontaneous breathing support and airway monitoring. The Babylog VN500 ventilation unit is used with Infinity C Series Dralger Medical Cockpits. The Babylog VN500 ventilation unit is intended for use in different medical care areas.
Babylog VN500 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/K093632 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093632: Infinity Acute Care System Workstation Neonatal Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093632
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