# K130584: Monitor B40

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems China Co., Ltd.
- Decided: Jun 26, 2013 after 113 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 71 ancestors in all.
8 later devices descend from it; 1 cites it directly.
5 of 80 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120598: Procare Monitor B40, Ge Medical Systems China Co., Ltd. (2012) Summary page 1.
- K102239: Carescape Monitor B650, GE Healthcare Finland Oy (2010) Summary page 1.
- K123195: Carescape Respiratory Modules, E-Sco, E-Scov, E-Scaiov and Accessories, GE Healthcare Finland Oy (2013) Summary page 1.

## Most influential descendants
- K133576: Monitor B40 (2014), 7 descendants of its own
- K151063: Monitor B40 (2015), 5 descendants of its own
- K171580: Monitor B125, Monitor B105 (2017), 4 descendants of its own
- K143676: B40i Patient Monitor (2015), 4 descendants of its own
- K201941: Monitor B125, Monitor B105 (2020), 3 descendants of its own

## Recalls of this device
- Sep 11, 2018 · Class II · Z-0584-2019: Patient monitors may restart due to network overload caused by network configuration.
- Oct 11, 2013 · Class II · Z-0489-2014: GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors. The B20, B30 and B40 Patient Monitors se

## Indications for use
The Monitor B40 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 Monitor B40 is intended for use under the direct supervision of a licensed health care practitioner. The Monitor B40 is not intended for use during MRI. The Monitor B40 can be a stand-alone monitor or interfaced to other devices via a network. The Monitor B40 monitors and displays: ECG (including ST segment, arrhythmia detection), invasive blood pressure, heart/pulse rate, osciliometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), functional oxygen saturation (Sp0O2) 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 (C0O2, 02, N20, anesthetic agents, anesthetic agent identification and resplratory rate) and Entropy.

Source page: https://510kreport.com/device/K130584
Methodology: https://510kreport.com/methodology