# K260656: Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare Finland Oy
- Decided: Sep 1, 2026 after 186 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K000815 (2000). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213234: CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201, Ge Medical Systems Information Technologies, Inc. (2022) Summary page 9.

## Indications for use
Carescape ONE: Carescape ONE is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. Carescape ONE is indicated for the monitoring of hemodynamic and respiratory physiological parameters. When the Carescape ONE is operated as a standalone multi-parameter physiological patient monitor, it provides the following physiological parameters: * ECG (heart rate, ST segment, and arrhythmia detection) * Pulse oximetry (pulse rate, functional oxygen saturation [SpO2]) * Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) * Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) * Temperature » Respiratory carbon dioxide (EtCO2, FICO2, and respiration rate) * Impedance respiration When the Carescape ONE is connected as an accessory to a compatible Host Monitor, it provides the following physiological parameters to the Host Monitor: * ECG (heart rate, ST segment, and arrhythmia detection) * Pulse oximetry (pulse rate, functional oxygen saturation [SpOZ2], and total hemoglobin concentration [SpHb]) * Non-invasive blood pressure (systolic, diastolic, and mean arterial pressures) * Invasive pressure (pulse rate and systolic, diastolic, and mean pressures) * Regional oxygen saturation (rSO2) * Temperature * Respiratory carbon dioxide (EtCO2, FiICO2, and respiration rate) * Impedance respiration When the Carescape ONE is connected as an accessory to a compatible host monitor, visual and audible alarms, user controls, and user interface are provided on the compatible host monitor and not on Carescape ONE. When Carescape ONE is operated as a transportable monitor, it can interface with a compatible host monitor to provide data for remote viewing and data management software devices via a network. Carescape ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. Carescape ONE 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. Contraindications for using Carescape ONE: The Carescape ONE is not intended for use within a controlled MR environment. Carescape Dock FO: Carescape Dock FO is intended for providing a DC power source to a docked Carescape ONE, which also charges the Carescape ONE battery. Carescape Dock FO is intended to provide a docked Carescape ONE with communication to the host monitor. The Carescape Dock FO is indicated for use in multiple areas within a professional healthcare facility. The Carescape Dock FO is indicated for use under the direct supervision of a licensed healthcare practitioner, or by person trained in proper use of the equipment in a professional healthcare facility. The Carescape Dock FO is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. Contraindications for using Carescape Dock FO: The Carescape Dock FO is not intended for use within a controlled MR environment. TruSignal ECG MM The TruSignal ECG MM is intended for monitoring of electrocardiogram and impedance respiration. TruSignal ECG MM is indicated for all hospital patients. The device is indicated for use by licensed healthcare practitioner. Contraindications for using the TruSignal ECG MM Device The TruSignal ECG MM is not intended for use within a controlled MR environment. TruSignal PRES MM The TruSignal PRES MM is intended for monitoring of invasive pressure and pulse rate. TruSignal PRES MM is indicated for all hospital patients. The device is indicated for use by licensed healthcare practitioner. Contraindications for using the TruSignal PRES MM Device The TruSignal PRES MM is not intended for use within a controlled MR environment. TruSignal TEMP MM The TrusSignal TEMP MM 1s intended for monitoring of temperature. [ruSignal TEMP MM is indicated for all hospital patients. The device is indicated for use by licensed healthcare practitioner. Contraindications for using the TruSignal TEMP MM Device The TruSignal TEMP MM is not intended for use within a controlled MR environment. TruSignal SpO2 MM 1.8M The TruSignal SpO2 MM 1.8M is intended for monitoring arterial oxygen saturation and pulse rate. TruSignal SpO2 MM 1.8M is indicated for all hospital patients. The device is indicated for use by licensed healthcare practitioner. Contraindications for using the TruSignal SpO2 MM 1.8M Device The TruSignal SpO2 MM 1.8M is not intended for use within a controlled MR environment. TruSignal SpO2 MM 3.0M The TruSignal SpO2 MM 3.0M is intended for monitoring arterial oxygen saturation and pulse rate. TruSignal SpO2 MM 3.0M is indicated for all hospital patients. The device is indicated for use by licensed healthcare practitioner. Contraindications for using the TruSignal SpO2 MM 3.0M Device The TruSignal SpO2 MM 3.0M is not intended for use within a controlled MR environment.

Source page: https://510kreport.com/device/K260656
Methodology: https://510kreport.com/methodology