# K083271: BSM-2300 &BSM6000 with CGS-9001 Series Communication Gateway, Model CGS-9001 Series Optional Accessory

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Dec 24, 2008 after 48 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). 11 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011918: Nihon  Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A Series, Nihon Kohden America, Inc. (2001)
- K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series, Nihon Kohden America, Inc. (2008) Summary page 1.

## Most influential descendants
- K112637: Netkonnect Remote Network Extension (2011), 1 descendant of its own
- K220989: Next Generation NetKonnect (2022), 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 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), noninvasive blood pressure (NIBP), invasive blood pressure (IBP), body temperature, carbon dioxide concentration (CO 2 and EtCO 2), and respiratory rate. The device may generate an audible and/or visible alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. This will be available for use by medical personnel on all patient populations.

Source page: https://510kreport.com/device/K083271
Methodology: https://510kreport.com/methodology