510(k) · Cleared
Recalled · Class II · 2026CARESCAPE Central Station V2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · DXJ Display, Cathode-Ray Tube, Medical
Cleared on Sep 15, 2016 as substantially equivalent to K133882 (Ge Medical Systems Information Technologies, Inc., 2014) and 3 other predicates after a 56-day review. Its family tree reaches back 9 generations to 1993. 7 later devices descend from it. It has been recalled 6 times.
- Decided
- Sep 15, 2016
- Review
- 56 days
- Class
- Class II
- Product code
- DXJ
- Recalls
- 6
- Predicates
- 4
Its longest line of descent runs back 9 generations to K921669 (1993). 27 ancestors in all, the oldest K820885 (1982). 7 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 5 generations between
- 3 generations backK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
- 2 generations backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- 1 generation backK133882 Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · Recalled
- This deviceK162012 CARESCAPE Central Station V2GE Healthcare · 2016
- Descendant · cites it directly · 3 of its ownK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
- Descendant · cites it directly · 2 of its ownK173107 Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc. · 2018
- Descendant · 3 generations on · 0 of its ownK242562 Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor…Ge Medical Systems Information Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK241728 Vios Monitoring System (TM) Model 2050; Vios Central Station…Murata Vios, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK921669 Marquette SL Series Transport Remote AcquisitionMarquette Electronics, Inc. · 1993
- 8 generations backK964750 Eagle 4000 Patient MonitorMarquette Electronics, Inc. · 1997
- 7 generations backK991735 Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6…General Electric Medical Systems Information Techn · 1999
- 6 generations backK014108 Mac 5000 Ecg Analysis SystemGeneral Electric Medical Systems Information Techn · 2002
- 5 generations backK033492 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2003
- 4 generations backK042177 Modification to Mac 5000 Ecg Analysis SystemGe Medical Systems Information Technologies · 2004
- 3 generations backK060833 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2006
- 2 generations backK092369 12SL Ecg Analysis ProgramGe Medical Systems Information Technologies · 2010
- 1 generation backK133882 Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · Recalled
- This deviceK162012 CARESCAPE Central Station V2GE Healthcare · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020 · cites it directly3descendants
- K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc. · 2022 · 2 generations on2descendants
- K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc. · 2018 · cites it directly2descendants
- K242562Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc. · 2025 · 3 generations on0descendants
- K241728Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios Central Server…Murata Vios, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K921669 | Marquette SL Series Transport Remote Acquisition | Marquette Electronics, Inc. | 1993 | — |
| −8 | K964750 | Eagle 4000 Patient Monitor | Marquette Electronics, Inc. | 1997 | — |
| −7 | K991735 | Mac Series Electrocardiographs Including Mac 5000, Mac PC, Mac 6, Mac VU, Mac… | General Electric Medical Systems Information Techn | 1999 | — |
| −6 | K014108 | Mac 5000 Ecg Analysis System | General Electric Medical Systems Information Techn | 2002 | — |
| −5 | K033492 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2003 | — |
| −4 | K042177 | Modification to Mac 5000 Ecg Analysis System | Ge Medical Systems Information Technologies | 2004 | — |
| −3 | K060833 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2006 | — |
| −2 | K092369 | 12SL Ecg Analysis Program | Ge Medical Systems Information Technologies | 2010 | — |
| −1 | K133882 | Carescape Central Station (Formally Known as Cic Pro) | Ge Medical Systems Information Technologies, Inc. | 2014 | 1 |
| 0 (this device) | K162012 | CARESCAPE Central Station V2 | GE Healthcare | 2016 | — |
| +1 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | — |
| +2 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 6 |
| +1 | K173107 | Vios Central Station Monitor Software, Vios Central Server Software | Vios Medical, Inc. | 2018 | — |
| +3 | K242562 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2025 | — |
| +2 | K241728 | Vios Monitoring System (TM) Model 2050; Vios Central Station Monitor/Vios… | Murata Vios, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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.
Planning a device in DXJ? 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 DXJ device
- #1 K261469 Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0…score 12.7 · 3 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 |
|---|---|---|---|
| * | K133882 | Carescape Central Station (Formally Known as Cic Pro)Summary page 5…JEG 21 CFR 868.1075 Argon gas analyzer CCI 21 CFR 868.1690 Nitrogen gas analyzer Predicate Device(s): CARESCAPE Central Station (K133882) MUSE ST Guard (K842308) 12SL V22 – ACS (K092369) MUSE CV (K110132… | 2014 |
| * | K842308 | 12SSL-SCSummary page 5…gas analyzer CCI 21 CFR 868.1690 Nitrogen gas analyzer Predicate Device(s): CARESCAPE Central Station (K133882) MUSE ST Guard (K842308) 12SL V22 – ACS (K092369) MUSE CV (K110132) Device Description: The CARESCAPE Central… | 1984 |
| * | K092369 | 12SL Ecg Analysis ProgramSummary page 5…68.1690 Nitrogen gas analyzer Predicate Device(s): CARESCAPE Central Station (K133882) MUSE ST Guard (K842308) 12SL V22 – ACS (K092369) MUSE CV (K110132) Device Description: The CARESCAPE Central Station (CSCS) is based on a PC… | 2010 |
| * | K110132 | Muse Cardiology Information SystemSummary page 5…e Device(s): CARESCAPE Central Station (K133882) MUSE ST Guard (K842308) 12SL V22 – ACS (K092369) MUSE CV (K110132) Device Description: The CARESCAPE Central Station (CSCS) is based on a PC technology platform and is user f… | 2011 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 30, 2026 | Class II | Z-3143-2026 | Under Investigation by firm | Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events. |
| Sep 5, 2025 | Class II | Z-0213-2026 | Software design | GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected… |
| Sep 5, 2025 | Class II | Z-0214-2026 | Software design | GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected… |
| May 10, 2022 | Class II | Z-1265-2022 | Process control | The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. |
| Jan 28, 2022 | Class II | Z-0808-2022 | Software design | If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms. |
| Jan 11, 2018 | Class II | Z-0487-2018 | Software in the Use Environment | CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 8 of the 27 ancestors have a recall of any class.
- Of its descendants, K201941 (Ge Medical Systems Information Technologies, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K133882.
How does its category compare?
All DXJ devicesDXJ Display, Cathode-Ray Tube, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DXJ
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · DXJ
130in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXJ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXJ
3in 2025
MAUDE reports naming product code DXJ, 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 | 1 | — | 0 | 3 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 8 | 29 |
| 2010 | 2 | — | 1 | 148 |
| 2011 | 4 | 53 | 1 | 129 |
| 2012 | 1 | — | 0 | 21 |
| 2013 | 3 | 174 | 0 | 4 |
| 2014 | 4 | 242 | 0 | 13 |
| 2015 | 2 | — | 0 | 15 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 4 | 164 | 0 | 10 |
| 2018 | 4 | 130 | 0 | 3 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 22 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The CARESCAPE Central Station is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment. The CARESCAPE Central Station is intended to collect, display and print information from a network, including patient demographics, physiological parameters and waveforms, alarm annunciation and/or other…
Read the full statement (188 words)
The CARESCAPE Central Station is intended for use under the direct supervision of a licensed healthcare practitioner.
The intended use is to provide clinicians with adult, pediatric and neonatal patient data within a hospital or clinical environment.
The CARESCAPE Central Station is intended to collect, display and print information from a network, including patient demographics, physiological parameters and waveforms, alarm annunciation and/or other non-medical information from monitors and telemetry systems. Physiological parameters and waveforms include electrocardiograph (ECG), pulse oximetry (SPO2), invasive blood pressures (IBP), non-invasive blood pressure (NIBP), respiration (RR), ventilator (VNT), carbon dioxide (CO2), oxygen (02), mass spectrometry (Gas), temperature (Temp) and bispectral index (BIS). Beat to beat patient information for parameters and waveforms from the bedside and telemetry systems can be displayed. Patient monitor and telemetry system settings can be adjusted. Parameter values derived from patient data can be calculated, displayed, and printed.
The CARESCAPE Central Station supports the ability to access information from GE products and hospital intranet in a web browser format. Additionally, CARESCAPE Central Station supports the ability to access patient information collected from the CARESCAPE network and stored on a network server.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162012: CARESCAPE Central Station V2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162012
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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