# K153580: Central Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Sep 7, 2016 after 267 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K833395 (1984). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103172: Civ-OB (Plus), Civnet Communication, Ltd. (2011) Summary page 4.

## Indications for use
Central Monitoring System Software is intended to conduct centralized antepartum and intrapartum monitoring of pregnant women’s vital sign information from compatible bedside monitors. The software collects, stores, displays and alarms the information provided on the bedside monitor. The monitoring parameters include Electrocardiogram(ECG), Heart Rate(HR), Respiration(RESP), Pulse Oxygen Saturation(SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), Impedance Cardiograph(ICG), TEMP(Temperature), Carbon dioxide (CO2), Anesthetic Gas (AG), Fetal Heart Rate (FHR), Uterine contraction (TOCO) and Fetal Movement (FM). It is intended to be used in the hospital or medical institutions, and it is not intended for home use.

Source page: https://510kreport.com/device/K153580
Methodology: https://510kreport.com/methodology