# K120598: Procare Monitor B40

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems China Co., Ltd.
- Decided: Jul 19, 2012 after 142 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: 7 generations back to K962603 (1997). 68 ancestors in all.
10 later devices descend from it; 2 cite it directly.
4 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043276: Datex-Ohmeda S/5TM FM with L-FICU04 and L-FICU04A Software and N-Fcrec Module, Datex-Ohmeda (2004) Summary page 2.
- K062576: Datex-Ohmeda S/5 E-PSM (P) Module (Consisting of E-PSM, E-PSMP and E-Intpsm Modules) and Accessories, GE Healthcare (2006) Summary page 2.
- K073203: Carescape V100, Ge Medical Systems Information Technologies (2007) Summary page 2.
- K102239: Carescape Monitor B650, GE Healthcare Finland Oy (2010) Summary page 2.

## Most influential descendants
- K130584: Monitor B40 (2013), 8 descendants of its own
- 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

## 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 PROCARE Monitor 840 is a portable multiparameter 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 PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophageal/Nasopharyngeal/Tympaiic/Rectal/Bl1adder/Axillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, and functional oxygen saturation (SpO2) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.

Source page: https://510kreport.com/device/K120598
Methodology: https://510kreport.com/methodology