510(k) · Cleared
Recalled · Class II · 2019Modification to Cic Pro Clinical Information Center
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · DSI Detector And Alarm, Arrhythmia
Cleared on Mar 16, 2007 as substantially equivalent to K053356 (Ge Medical Systems Information Technologies, 2006) after a 168-day review. Its family tree reaches back 3 generations to 2000. 10 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 16, 2007
- Review
- 168 days
- Class
- Class II
- Product code
- DSI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001112 (2000). 10 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK001112 GE Marquette Clinical Information Center, GE Marquette CicGeneral Electric Medical Systems Information Techn · 2000
- 2 generations backK032370 Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies · 2003 · Recalled
- 1 generation backK053356 Modification to: Cic Pro Clinical Information Center Central StationGe Medical Systems Information Technologies · 2006 · Recalled
- This deviceK062976 Modification to Cic Pro Clinical Information CenterGe Medical Systems Information Technologies · 2007
- Descendant · cites it directly · 9 of its ownK133882 Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 7 of its ownK162012 CARESCAPE Central Station V2GE Healthcare · 2016 · Recalled
- Descendant · 3 generations on · 3 of its ownK201941 Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK213490 Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor…Ge Medical Systems Information Technologies, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 2 of its ownK173107 Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc. · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K133882Carescape Central Station (Formally Known as Cic Pro)Ge Medical Systems Information Technologies, Inc. · 2014 · cites it directly9descendants
- K162012CARESCAPE Central Station V2GE Healthcare · 2016 · 2 generations on7descendants
- K201941Monitor B125, Monitor B105Ge Medical Systems Information Technologies, Inc. · 2020 · 3 generations on3descendants
- K213490Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125PGe Medical Systems Information Technologies, Inc. · 2022 · 4 generations on2descendants
- K173107Vios Central Station Monitor Software, Vios Central Server SoftwareVios Medical, Inc. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001112 | GE Marquette Clinical Information Center, GE Marquette Cic | General Electric Medical Systems Information Techn | 2000 | — |
| −2 | K032370 | Cic Pro Clinical Information Center Central Station | Ge Medical Systems Information Technologies | 2003 | 5 |
| −1 | K053356 | Modification to: Cic Pro Clinical Information Center Central Station | Ge Medical Systems Information Technologies | 2006 | 2 |
| 0 (this device) | K062976 | Modification to Cic Pro Clinical Information Center | Ge Medical Systems Information Technologies | 2007 | — |
| +1 | K133882 | Carescape Central Station (Formally Known as Cic Pro) | Ge Medical Systems Information Technologies, Inc. | 2014 | 1 |
| +2 | K162012 | CARESCAPE Central Station V2 | GE Healthcare | 2016 | 6 |
| +3 | K201941 | Monitor B125, Monitor B105 | Ge Medical Systems Information Technologies, Inc. | 2020 | — |
| +4 | K213490 | Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P | Ge Medical Systems Information Technologies, Inc. | 2022 | 6 |
| +3 | K173107 | Vios Central Station Monitor Software, Vios Central Server Software | Vios Medical, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 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 DSI? 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 DSI device
- #1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K053356 | Modification to: Cic Pro Clinical Information Center Central StationSummary page 1…CIC Pro Clinical Information Center is classified as: 21 CFR 870.2450 Display, Cathode-ray Tube, Medical Predicate Device: K053356:CIC Pro Clinical Information Center Device Description: The CIC Pro Clinical Information Center is based on a standar… | 2006 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133882 | Carescape Central Station (Formally Known as Cic Pro) | 2014 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2019 | Class II | Z-0726-2020 | Software in the Use Environment | When connected to the Mission Critical (MC) and /or Information Exchange (IX) networks, certain versions of the CARESCAPE Telemetry Server, ApexPro Telemetry Server, CARESCAPE Central Station (CSCS) version 1 and Central Information… |
| Mar 10, 2009 | Not classified | Z-1600-2009 | Component change control | GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety. |
| Feb 27, 2009 | Not classified | Z-1232-2009 | Software design | GE Healthcare is aware of potential network time issues associated with the time change aspects of certain CARESCAPE CIC Pro" software versions. These issues may impact patient safety. No reported patient injuries or illnesses for the use… |
| Nov 8, 2007 | Not classified | Z-0519-2008 | Software design | Potential for Loss of Audible Alarming and ECG Tab Setting Changes; from Clinical Informaiton Center (CIC) Pro v5.0.3 & 5.0.6 when used in combination with Telemetry and bedside monitors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K133882 (Ge Medical Systems Information Technologies, Inc., 2014) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K053356.
How does its category compare?
All DSI devicesDSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DSI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSI
243in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSI
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSI
712in 2025
MAUDE reports naming product code DSI, 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 | 7 | 151 | 4 | 64 |
| 2008 | 5 | 70 | 8 | 156 |
| 2009 | 6 | 73 | 3 | 279 |
| 2010 | 6 | 111 | 5 | 823 |
| 2011 | 6 | 114 | 3 | 793 |
| 2012 | 3 | 113 | 1 | 766 |
| 2013 | 1 | — | 0 | 795 |
| 2014 | 4 | 200 | 0 | 1,000 |
| 2015 | 9 | 127 | 0 | 1,645 |
| 2016 | 6 | 224 | 0 | 4,352 |
| 2017 | 0 | — | 0 | 3,594 |
| 2018 | 2 | — | 1 | 3,648 |
| 2019 | 3 | 243 | 4 | 3,485 |
| 2020 | 2 | — | 2 | 3,084 |
| 2021 | 0 | — | 0 | 3,092 |
| 2022 | 0 | — | 1 | 1,638 |
| 2023 | 2 | — | 2 | 1,616 |
| 2024 | 1 | — | 0 | 1,320 |
| 2025 | 1 | — | 18 | 712 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The CIC Pro Clinical Information Center 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 in a centralized location within a hospital or clinical environment. CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes…
Read the full statement (172 words)
The CIC Pro Clinical Information Center 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 in a centralized location within a hospital or clinical environment.
CIC Pro Clinical Information Center central station is intended to collect information from a network and display this data. This data includes physiological, patient demographic and/or other non-medical information. Physiological parameters and waveforms from monitors and telemetry systems can be displayed and printed from the CIC Pro Clinical Information Center central station. Beat to beat patient information for all parameters and waveforms from the bedside and telemetry systems can be displayed.
The CIC Pro Clinical Information Center central station supports the ability to access information from the CIC Pro Clinical Information Center central stations' products in a web browser format. Additionally, the CIC Pro Clinical Information Center central station supports the ability to access patient information collected from the unity network and stored on a network server.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062976: Modification to Cic Pro Clinical Information Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062976
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