# K200494: CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES

- Pathway: 510(k) (Special)
- Applicant: GE Healthcare
- Decided: Mar 29, 2020 after 30 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: 8 generations back to K000815 (2000). 23 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190008: Carescape One, GE Healthcare (2019) Summary page 6.

## Most influential descendants
- 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 (2022), 3 descendants of its own
- K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (2022), 2 descendants of its own
- K212876: Carescape SpO2 - Masimo (2021), 2 descendants of its own
- K223498: Radius VSM and Accessories (2023), 1 descendant of its own
- K221953: Masimo CARESCAPE SpO2 – Masimo with SpHb (2022), 1 descendant of its own

## Recalls of this device
- Jun 22, 2020 · Class II · Z-2750-2020: CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor.

## Indications for use
The 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. The CARESCAPE ONE is indicated for the monitoring of hemodynamic (including ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, and temperature), and respiratory (impedance respiration and CO2 airway gas) physiological parameters. The CARESCAPE ONE can be used as a standalone monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition and monitoring. The CARESCAPE ONE can be connected as an accessory to a compatible CARESCAPE monitor. In this mode of operation, the CARESCAPE ONE provides ECG, ST segment, arrhythmia detection, invasive pressure, non-invasive blood pressure, SpO2, pulse rate, temperature, impedance respiration, and CO2 airway gas parameter acquisition. Visual and audible alarms, user controls, and user interface on the CARESCAPE ONE are not active in this mode. The CARESCAPE ONE is indicated for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE ONE is indicated 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/K200494
Methodology: https://510kreport.com/methodology