# K211619: Multi-Parameter Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Comen Medical Instruments Co.,Ltd
- Decided: Dec 29, 2022 after 582 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: 39 generations back to K941811 (1994). 278 ancestors in all.
No later device cites it as a predicate yet.
1 of 279 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191106: C50 and C80 Multi-parameter Patient Monitor, Shenzhen Comen Medical Instruments Co.,Ltd (2019) Summary page 5.

## Indications for use
The NC10 and NC12 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters. These parameters include ECG (3-lead, 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), anesthetic gas (AG), and Bispectral index (BIS) for a single patient. All parameters can be monitored on single adult, pediatric, and neonatal patients except: • BIS monitoring is intended for adult and pediatric patients only; • C.O. monitoring is restricted to adult patients only; • Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population. • When using COMEM SpO2, the monitor is intended to be used on adult patients only. • NIBP measurement continual mode is not applicable to neonates. The monitors are to be used in general healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. The monitors are not intended for helicopter transport, hospital ambulance, or home use. The monitors do not measure, display, or trend changes in the ST segment. The monitors do not intend for use as apnea monitors. The monitors are not intended for use in MRI or CT environments. The monitors are not used on patients who have a demonstrated need for cardiac monitoring known arrhythmias of VT, Accelerated Idioventricular rhythm and Torsades de Pointes.

Source page: https://510kreport.com/device/K211619
Methodology: https://510kreport.com/methodology