# K133882: Carescape Central Station (Formally Known as Cic Pro)

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Apr 30, 2014 after 131 days
- Product code: DXJ (Display, Cathode-Ray Tube, Medical)
- Device class: 2
- Regulation: 21 CFR 870.2450
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K921669 (1993). 26 ancestors in all.
9 later devices descend from it; 2 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062976: Modification to Cic Pro Clinical Information Center, Ge Medical Systems Information Technologies (2007) Summary page 3.
- K092369: 12SL Ecg Analysis Program, Ge Medical Systems Information Technologies (2010) Summary page 3.
- K110132: Muse Cardiology Information System, Ge Medical Systems Information Technologies, Inc. (2011) Summary page 9.

## Cited in the summary but kept off the family tree
- K042308: Sheath-in-Sheath Catheter, 18FR, Model S00018; Sheath-in-Sheath Catheter, 6 FR., Model S00019, Facile Medical, Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K162012: CARESCAPE Central Station V2 (2016), 7 descendants of its own
- K201941: Monitor B125, Monitor B105 (2020), 3 descendants of its own
- K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (2022), 2 descendants of its own
- K173107: Vios Central Station Monitor Software, Vios Central Server Software (2018), 2 descendants of its own
- K242562: Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (2025), 0 descendants of its own

## Recalls of this device
- Nov 12, 2019 · Class II · Z-0727-2020: 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) v

## Indications for use
The CARESCAPE Central Station is intended for use under the direct supervision ofa 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 wavefonns include electrocardiograph (ECG), pulse oximetry (SPO2). invasive blood pressures (IBP), non-invasive blood pressure (NIBP), respiration (RR), ventilator (VNT). carbon dioxide (C02), oxygen (02), mass spectrometry (Gas), temperature (Temp) and bispectral index (B15). 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.

Source page: https://510kreport.com/device/K133882
Methodology: https://510kreport.com/methodology