# K203435: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Jul 16, 2021 after 235 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: 8 generations back to K951127 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201949: Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series, Nihon Kohden Corporation (2021). Cleared while this submission was under review Summary page 7.

## Indications for use
The Nihon Kohden Life Scope® G5 and Nihon Kohden Life Scope® G7 Bedside Monitoring System are intended to monitor, display and record physiological data to provide cardiac and vital signs monitoring within a medical facility. The device is intended to produce a visual record of the electrical signal produced by the heart and monitor the electrocardiogram to generate visible and/or audible alarms when an arrhythmia exists. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, BIS, cardiac output (CO), oxygen concentration (O2), carbon dioxide concentration (CO2), EtCO2, respiratory rate, inspired and expired anesthetic agents and anesthetic gases including N2O, halothane, isoflurane, enflurane, sevoflurane, and desflurane. The device also displays patient data from external devices such as ventilators, TOF modules, CCO/SvO2 monitors, and EEG measuring units. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device will be available for use by trained medical personnel within a medical facility on all patient populations, including adult, neonate, infant, child, and adolescent subgroups. A-fib detection, ST measurement and QTc/QRSd monitoring intended for adult patient . rrhythmia detection function is intended for adolescent and .

Source page: https://510kreport.com/device/K203435
Methodology: https://510kreport.com/methodology