# K131223: Carescape Monitor B650

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare Finland Oy
- Decided: Aug 28, 2013 after 120 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K000815 (2000). 21 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102239: Carescape Monitor B650, GE Healthcare Finland Oy (2010) Summary page 1.

## Most influential descendants
- K191149: Carescape B650 (2020), 7 descendants of its own
- K213181: CARESCAPE B650, E-musb (2022), 6 descendants of its own
- K230579: Smart Wedge algorithm (2023), 5 descendants of its own
- K242451: HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) (2024), 4 descendants of its own
- K191249: Carescape B450 (2020), 4 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
- Jun 13, 2014 · Class II · Z-2085-2014: Partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may 
- 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

## 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 8650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor 8650 is indicated for monitoring of: "hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry. cardiac output (therrnodilution and pulse contour), temperature, mixed venous oxygen saturation, and central venous oxygen saturation), " Respiratory (impedance respiration, airway gases (C02, 02, N20 and anesthetic agents), spirometry, gas exchange) and * neurophysiological status (including electroencephalography, Entropy, Bispectral Index (815), and neuromuscular transmission), The CARESCAPE Monitor 8650 also provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. 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 CARESCAPE 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 MR.I.

Source page: https://510kreport.com/device/K131223
Methodology: https://510kreport.com/methodology