# K151080: Nihon Kohden CSM 1901 Bedside Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden
- Decided: Nov 5, 2015 after 197 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K951127 (1995). 11 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082785: Nihon Kohden Bedside Monitor, BSM 9100A Series, Nihon Kohden America, Inc. (2008) Summary page 4.

## Most influential descendants
- K201949: Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series (2021), 3 descendants of its own
- K213316: Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM (2021), 1 descendant of its own
- K220976: Life Scope PT BSM-1700 Series Bedside Monitor (2022), 0 descendants of its own
- K203435: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System (2021), 0 descendants of its own

## Recalls of this device
- Mar 13, 2017 · Class II · Z-1768-2017: The Pause function on central monitors will not automatically resume when connected to a Life Scope G9 patient monitor.

## Indications for use
The Nihon Kohden CSM-1901 Bedside Monitor is 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 (FiO2), 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 monitors, CCO/SvO2 monitors, and EEG measuring unit. The device may generate and 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.

Source page: https://510kreport.com/device/K151080
Methodology: https://510kreport.com/methodology