# K143676: B40i Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare Finland Oy
- Decided: Jul 31, 2015 after 219 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: 10 generations back to K962603 (1997). 73 ancestors in all.
4 later devices descend from it; 1 cites it directly.
5 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133576: Monitor B40, Ge Medical Systems China Co., Ltd. (2014) Summary page 5.
- K071073: Solar 8000 and Transport Pro with Patient Data Module, Ge Medical Systems Information Technologies (2007) Summary page 5.
- K042642: Aware Transport Monitor System (Includes Aware Pod and Aware Transport Monitor), Ge Medical Systems Information Technologies (2004) 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-0586-2019: Patient monitors may restart due to network overload caused by network configuration.

## Indications for use
The B40i is a portable multi-parameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The B40i is intended for use under the direct supervision of a licensed health care practitioner. The B40i is not intended for use during MRI. The B40i can be a stand-alone monitor or interfaced to other devices via a network. The B40i monitors and displays: ECG (including ST segment, arrhythmia detection), 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) and Entropy.

Source page: https://510kreport.com/device/K143676
Methodology: https://510kreport.com/methodology