# K171580: Monitor B125, Monitor B105

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems (China) Co., Ltd.
- Decided: Nov 1, 2017 after 154 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: 11 generations back to K962603 (1997). 74 ancestors in all.
4 later devices descend from it; 1 cites it directly.
5 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151063: Monitor B40, Ge Medical Systems China Co., Ltd. (2015) Summary page 5.
- K102239: Carescape Monitor B650, GE Healthcare Finland Oy (2010) Summary page 5.

## Most influential descendants
- K201941: Monitor B125, Monitor B105 (2020), 3 descendants of its own
- K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (2022), 2 descendants of its own
- 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 11, 2018 · Class II · Z-0587-2019: Patient monitors may restart due to network overload caused by network configuration.

## Indications for use
The Monitor B125/B105 is a portable multi-parameter unit 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 B125/B105 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B125/B105 is not intended for use during MRI. The Monitor B125/B105 can be a stand-alone monitor or interfaced to other devices via network. The Monitor B125/B105 monitors and displays : 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, CO2. The Monitor B125/B105 is 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, Multifocal PVCs, Missing Beat, Premature Ventricular Contraction (PVC) and Ventricular fibrillation.

Source page: https://510kreport.com/device/K171580
Methodology: https://510kreport.com/methodology