# K112190: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mediana Co., Ltd.
- Decided: Nov 9, 2011 after 103 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 63 ancestors in all.
No later device cites it as a predicate yet.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082812: Omron Model HBP-2070 Vital Signs Monitor, Omron Healthcare, Inc. (2008) Summary page 1.
- K062095: Mcare 300 Vital Signs Monitor, Model 91220, Spacelabs Medical, Inc. (2006) Summary page 1.
- K063690: Colin Press Mate, Model BP S510, Omron Healthcare, Inc. (2007) Summary page 1.
- K100217: Lucon M-Series Patient Monitor, Models M20 and M30, Mediana Co., Ltd. (2010) Summary page 1.

## Indications for use
The YM6000 monitor is intended to be used to monitor electrocardiography, heart rate, pulse rate, noninvasive blood pressure (systolic, diastolic and mean arterial pressures), functional arterial oxygen saturation, invasive blood pressure, respiration, capnography (EtCO 2 and InCa 2) and temperature for adult, pediatric and neonate patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. Note: Hospital use typically includes such areas as general care floors, operating rooms, special procedure areas, intensive and critical care area, within the hospital. Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers. Note: The medically skilled and trained user can be any clinicians like doctor and nurse who know how to take and interpret a patient's vital signs. These clinicians must take the direct responsibility for patient life. It can include a care-giver or medically trained intern reter who is authorized under the appropriate clinical facility procedure to support the patient care. Any inappropriate setting, especially the limit alarm or alarm notification setting can lead the hazardous situation that injures the patient or harms the patient or threats the patient life. The special attention to assign the trained user who can adjust the patient setting of the patient monitor should be essentially paid.

Source page: https://510kreport.com/device/K112190
Methodology: https://510kreport.com/methodology