# K122253: Procare Monitor B20

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems China Co., Ltd.
- Decided: Mar 22, 2013 after 238 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). 69 ancestors in all.
No later device cites it as a predicate yet.
3 of 70 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.

## Recalls of this device
- Sep 11, 2018 · Class II · Z-0583-2019: 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 B20 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 B20 is intended for use uinder the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MIII. The PROCARE Monitor B20 monitors and displays oscillometric nion-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, EGG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esophagea]INasopharyngeaV/Tymnpanic/Rectal/Bladder/Mxillary/Skin/Airway/Room/Myocardial/Core/Surface temperature, and functional oxygen saturation (Sp0 2 ) and pulse rate via continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.

Source page: https://510kreport.com/device/K122253
Methodology: https://510kreport.com/methodology