# K102239: Carescape Monitor B650

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare Finland Oy
- Decided: Oct 18, 2010 after 70 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K000815 (2000). 20 ancestors in all.
32 later devices descend from it; 5 cite it directly.
1 of 53 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092027: Carescape Monitor B850, Ge Medical Systems Information Technologies (2009) Summary page 2.
- K061185: Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE05A and L-CANE05A Software, GE Healthcare (2006) Summary page 2.
- K031320: EK-Pro Arrhythmia Detection Algorithm, Ge Medical Systems Information Technologies (2003) Summary page 2.
- K092680: Datex-Ohmeda S/5 Anesthesia Monitor with L-ANEO7 and L-ANEO7A Software Using F-CU8 or F-CU5 (P) Monitor Frame Options an, GE Healthcare Finland Oy (2009) Summary page 2.

## Most influential descendants
- K132533: Carescape Monitor B450 (2013), 14 descendants of its own
- K131223: Carescape Monitor B650 (2013), 13 descendants of its own
- K190008: Carescape One (2019), 11 descendants of its own
- K200494: CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES (2020), 10 descendants of its own
- K120598: Procare Monitor B40 (2012), 10 descendants of its own

## Recalls of this device
- May 25, 2018 · Class II · Z-2340-2018: When multiple CARESCAPE Monitor B650 units are connected to the same network and a network overload occurs for a prolonged time, the monitors may simultaneously restart as designed. The monitor restar
- May 4, 2015 · Class II · Z-1606-2015: The heart rate could be calculated from pacer pulses without indication that pacemaker detection is OFF in some combinations of Bx50 monitors, a PDM, and CIC/CSCS. Then the monitor does not show the P
- Jul 7, 2014 · Class II · Z-2114-2014: Possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may ex
- Feb 28, 2014 · Class II · Z-1175-2014: GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) a
- Dec 27, 2013 · Class II · Z-0854-2014: GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These included 25 issues related to NIBP (Non-InvasiVentilatio
- Jul 12, 2012 · Class II · Z-2256-2013: GE Healthcare has recently become aware of a number of potential issues associated with the CARESCAPE Monitor B650. No injuries or illnesses have been reported.
- Sep 30, 2011 · Class II · Z-0823-2013: GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. There have been no reported illnesses or injuries that have occurred with the use of the device.
- Mar 23, 2011 · Not classified · Z-1930-2011: GE Healthcare has become aware of a potential safety issue associated with the CARESCAPE Monitor B650 & B850 Cardiac Output measurement using Patient Data Module (PDM), and activation of ECG Leads Off

## Indications for use
The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynarniic (including EGG, ST segment, arrhythmia detection, ECU diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (HI1S) and neuromuscular transmission) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARiESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI.

Source page: https://510kreport.com/device/K102239
Methodology: https://510kreport.com/methodology