# 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

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Apr 12, 2022 after 194 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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: 9 generations back to K000815 (2000). 24 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200494: CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES, GE Healthcare (2020) Summary page 8.

## Most influential descendants
- K221953: Masimo CARESCAPE SpO2 – Masimo with SpHb (2022), 1 descendant of its own
- 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 (2026), 0 descendants of its own
- K232389: Carescape SpO2 - Masimo; Masimo rainbow SET IntelliVue (2023), 0 descendants of its own

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0454-2026: Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will 

## Indications for use
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 [SpO2], 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, FiCO2, 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. CARESCAPE ONE is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. Regional oxygen saturation (rSO2) is an adjunct parameter for noninvasive monitoring of cerebral/somatic regional oximetry of blood in the brain or other tissue beneath the sensor. It is intended to be used on patients greater than 40 kg (88 lbs) at risk for reduced-flow or no-flow ischemic states. CARESCAPE ONE is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in the 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.

Source page: https://510kreport.com/device/K213234
Methodology: https://510kreport.com/methodology