# K133576: Monitor B40

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems China Co., Ltd.
- Decided: Feb 21, 2014 after 93 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 72 ancestors in all.
7 later devices descend from it; 2 cite 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)
- K130584: Monitor B40, Ge Medical Systems China Co., Ltd. (2013) Summary page 2.

## Most influential descendants
- 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
- K213490: Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P (2022), 2 descendants of its own

## Recalls of this device
- Sep 27, 2019 · Class I · Z-0760-2020: Displayed End Tidal Oxygen (EtO2) and Fraction of Inspired Oxygen (FiO2) values may be incorrect which could cause up to 50% measurement error in the EtO2/FiO2 values.
- Sep 11, 2018 · Class II · Z-0584-2019: Patient monitors may restart due to network overload caused by network configuration.
- Aug 8, 2014 · Class II · Z-2617-2014: GE Healthcare has recently become aware of a potential safety issue due to a failure of an O2 sensor component associated with the CARESCAPE respiratory modules, the Airway Gas Option and their respec

## 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 840 can be a stand-at-one 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, 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 (C02, 02, N2Q, anesthetic agents, anesthetic agent identification and respiratory rate) and Entropy.

Source page: https://510kreport.com/device/K133576
Methodology: https://510kreport.com/methodology