# K112877: Comen Multi-Parameter Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Goldway (Us), Inc.
- Decided: Nov 7, 2012 after 404 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K941811 (1994). 102 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021154: Goldway Patient Monitor, Model # UT4000F, Goldway Us, Inc. (2003) Summary page 1.
- K033988: Goldway UT4000A Vital Signs Monitor, Goldway (Us), Inc. (2004) Summary page 1.
- K060281: VS-800 Vital Signs Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 1.
- K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 1.
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.

## Most influential descendants
- K173454: Multi-parameter Patient Monitor, models C30 (2018), 0 descendants of its own

## Indications for use
Comen Multi-Parameter Patient Monitor models C50, 060, C80 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be made available to the user from the monitor. The monitor models monitor parameters such as ECG (3-lead, 5-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both. The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans. The monitor models are not designed for home use, and are restricted to be used on one patient at a time.

Source page: https://510kreport.com/device/K112877
Methodology: https://510kreport.com/methodology