# K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies, Inc.
- Decided: Apr 1, 2022 after 151 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 34 generations back to K941811 (1994). 390 ancestors in all.
2 later devices descend from it; 2 cite it directly.
7 of 393 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201941: Monitor B125, Monitor B105, Ge Medical Systems Information Technologies, Inc. (2020) Summary page 6.
- K191249: Carescape B450, GE Healthcare Finland Oy (2020) Summary page 6.
- K133810: VC150 Vital Signs Monitor, Innokas Yhtyma (2014) Summary page 6.
- K200494: CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES, GE Healthcare (2020) Summary page 6.

## Most influential descendants
- K242562: Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125P (2025), 0 descendants of its own
- K233810: Portrait VSM (2024), 0 descendants of its own

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0455-2026: 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 
- Nov 16, 2022 · Class II · Z-0733-2023: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used i
- Nov 16, 2022 · Class II · Z-0729-2023: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used i
- Nov 16, 2022 · Class II · Z-0730-2023: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used i
- Nov 16, 2022 · Class II · Z-0732-2023: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used i
- Nov 16, 2022 · Class II · Z-0731-2023: GE Healthcare has become aware that if certain B1x5P / B1x5M patient monitors use "mmHg" or "kPa" as the unit for CO2 measurement, the displayed value for CO2 measurement can be inaccurate when used i

## Indications for use
The monitor B105M, B125M, B155M, B105P and B125P are portable multi-parameter patient monitors intended to be used for monitoring, recording, and to generate alarms for multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The monitor B105M, B125M, B155M, B105P and B125P are intended for use under the direct supervision of a licensed health care practitioner. The monitor B105M, B125M, B155M, B105P and B125P are not intended for use during MRI. The monitor B105M, B125M, B155M, B105P and B125P can be stand-alone monitors or interfaced to other devices via network. The monitor B105M, B125M, B155M, B105P and B125P monitor and display: ECG (including ST segment, arrhythmia detection, ECG diagnostic analysis and measurement), invasive blood pressure, heart/pulse rate, oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (SpO2) and pulse rate via continuous monitoring( including monitoring during conditions of clinical patient motion or low perfusion), temperature with a reusable or disposable electronic thermometer for continual monitoring Esophageal/Nasopharyngeal/Tympanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, impedance respiration, respiration rate, airway gases (CO2, 02, N20, anesthetic agents, anesthetic agent identification and respiratory rate), Cardiac Output (C.O.), Entropy and neuromuscular transmission (NMT). The monitor B105M, B125M, B155M, B105P and B125P are able to detect and generate alarms for ECG arrhythmias: Asystole, Ventricular tachycardia, VT>2, Ventricular Bradycardia, Accelerated Ventricular Rhythm, Ventricular Couplet, Bigeminy, Trigeminy, “R on T”, Tachycardia, Bradycardia, Pause, Atrial Fibrillation, Irregular, Multifocal PVCs, Missing Beat, SV Tachy, Premature Ventricular Contraction (PVC), Supra Ventricular Contraction (SVC) and Ventricular fibrillation.

Source page: https://510kreport.com/device/K213490
Methodology: https://510kreport.com/methodology