# K173454: Multi-parameter Patient Monitor, models C30

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Comen Medical Instruments Co.,Ltd
- Decided: Aug 16, 2018 after 283 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: 14 generations back to K941811 (1994). 105 ancestors in all.
No later device cites it as a predicate yet.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123074: Imec, Ipm and Beneview T1 Patient Monitors, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2013) Summary page 5.
- K112877: Comen Multi-Parameter Patient Monitor, Goldway (Us), Inc. (2012) Summary page 5.

## Indications for use
C30 Multi-parameter Patient Monitor (hereinafter called Patient Monitor) is indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. It’s used for monitoring, reviewing and storing of multiple physiological parameters as following: ECG, heart rate (HR), respiration (Resp), temperature (Temp), SpO2, pulse rate (PR), non-invasive blood pressure (NIBP) of single patient. All parameters can be applied to adult, pediatric or neonate. The Patient Monitor is not intended to be used on the patients with pacemaker. The monitor is used for monitoring the clinical patients, so only the doctors and nurses who are qualified through training can use these monitors.

Source page: https://510kreport.com/device/K173454
Methodology: https://510kreport.com/methodology