# K082785: Nihon Kohden Bedside Monitor, BSM 9100A Series

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Nov 26, 2008 after 64 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: 5 generations back to K951127 (1995). 10 ancestors in all.
5 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)
- K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series, Nihon Kohden America, Inc. (2008) Summary page 1.

## Most influential descendants
- K151080: Nihon Kohden CSM 1901 Bedside Monitor (2015), 4 descendants of its own
- 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

## Indications for use
The device 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 signals 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), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, Cardiac Output (CO), oxygen concentration (FiO 2), Carbon dioxide Concentration (C0 2) and EtCO 2, respiratory rate, BIS and inspired and expired anesthetic agents and gases including C0 2, 02, N 2 0, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane. Anesthetic agents and gases are detected using the cleared AG-920RA Anesthetic Agent Detection System K020046 cleared for distribution on July 23, 2002. The device also monitors Ventilators, CO 2 Monitors, TOF Monitors, BIS Monitors and CCO/SvO 2 Monitors .The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits.

Source page: https://510kreport.com/device/K082785
Methodology: https://510kreport.com/methodology