# K191106: C50 and C80 Multi-parameter Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Comen Medical Instruments Co.,Ltd
- Decided: Dec 13, 2019 after 232 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: 38 generations back to K941811 (1994). 277 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 279 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170876: Passport Series Patient Monitors (Passport 12m, Passport 17m), Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K211619: Multi-Parameter Patient Monitor (2022), 0 descendants of its own

## Indications for use
The C50 and C80 patient monitors are intended to be used for monitoring, displaying, reviewing, alarming and storing of multiple physiological parameters as following: ECG (3-lead , 5-lead or 12-lead selectable, arrhythmia detection, heart rate (HR)), Respiration rate (RR), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP), temperature (Temp), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG), cardiac output (C.O.) for single patient. The C80 can also monitor the ICG (impedance cardiography) and BIS (bispectral index). All the parameters can be monitored on single adult, pediatric, and neonatal patients with the exception of the following: • The ICG monitoring is applicable to the adult patients of 122~229cm in height and 30~159Kg (67~341 pounds) in weight only; • NIBP measurement continual mode is not applicable to neonates; • Anesthetic depth (BIS) of the multi-parameter patient monitor is not intended for neonatal patients; 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 home use.

Source page: https://510kreport.com/device/K191106
Methodology: https://510kreport.com/methodology