# K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Feb 26, 2008 after 18 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: 4 generations back to K951127 (1995). 9 ancestors in all.
11 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030105: Anesthesia Monitor; Bedside Monitor, Series BSM-5130A, Nihon Kohden America, Inc. (2003) Summary page 1.
- K071058: Multiple Patient Receiver, Model Org-9700A, Nihon Kohden America, Inc. (2007) Summary page 1.

## Most influential descendants
- K082785: Nihon Kohden Bedside Monitor, BSM 9100A Series (2008), 5 descendants of its own
- 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
- K083271: BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series Optional Accessory (2008), 2 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

## 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 audible and/or visible 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), continuous non-invasive blood pressure (CNIBP), invasive blood pressure (JBP), body temperature, BIS, Cardiac Output (CO), oxygen concentration (FiO 2), carbon dioxide concentration (CO 2) and EtCO 2, respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N 2 0, Halothane, Isoflurane, Enflurane, Sevoflurane and Desfiurane. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. This device may also be used to condition and transmit physiological signals via radio frequency. The device will be available for use by medical personnel on patients within a medical facility on all patient populations.

Source page: https://510kreport.com/device/K080342
Methodology: https://510kreport.com/methodology