# K100217: Lucon M-Series Patient Monitor, Models M20 and M30

- Pathway: 510(k) (Traditional)
- Applicant: Mediana Co., Ltd.
- Decided: Jun 8, 2010 after 134 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: 8 generations back to K962603 (1997). 62 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 2.
- K080495: Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3, Philips Medical Systems (2008) Summary page 1.
- K012451: Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246, Welch Allyn Protocol, Inc. (2001) Summary page 1.
- K062095: Mcare 300 Vital Signs Monitor, Model 91220, Spacelabs Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K112190: Patient Monitor (2011), 0 descendants of its own

## Indications for use
The Lucon M-series (M20, M30) is intended to be used to monitor for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician. The device is capable of monitoring: * Electrocardiography (ECG) * Heart rate (HR) * Noninvasive blood pressure (NIBP) * Functional arterial oxygen saturation (SpO2) * Pulse rate (PR) * Respiration rate (RR) * Temperature (Temp) * Arrhythmia/ST segment (M30 only) * Capnography (M30 only) 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, surgical centers, and sub acute care centers. Note: The medically skilled and trained user can be clinicians like doctors and nurses who know how to take and interpret a patient's vital signs. These clinicians must take direct responsibility for the patient's life. This can include care-givers or medically trained interpreters who are authorized under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, especially the alarm limit or alarm notification settings, can lead to a hazardous situation that injures the patient, harms the patient, or threatens the patient's life. This equipment should only be operated by trained users who can adjust the settings of the patient monitor.

Source page: https://510kreport.com/device/K100217
Methodology: https://510kreport.com/methodology