# K011918: Nihon  Kohden BSM-2300A Series Bedside Monitor and Accessories, Model BSM-2300A Series

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Sep 12, 2001 after 84 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: 1 generation back to K001693 (2000). 1 ancestor in all.
20 later devices descend from it; 5 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001693: Life Scope P, Model BSM-4100 Series, Nihon Kohden America, Inc. (2000) Summary page 1.

## Most influential descendants
- K113165: Mini-Medic (2012), 13 descendants of its own
- K190792: BB-613WP (2019), 12 descendants of its own
- K212153: Biobeat Platform, BB-613WP Patch (2022), 5 descendants of its own
- K242018: UbiqVue™ 2A Multi-parameter System (UX2550) (2024), 2 descendants of its own
- K222658: Accurate 24 Non-invasive blood pressure monitor (2023), 2 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 (SpO_) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, carbon dioxide concentration (CO, and EtCO,), and respiratory rate. The device may generate an audible and/or visual alarm when a measured rate falls outside preset limits. The device may also condition and transmit physiological signals via radio frequency. The device will be available for use by medical personnel on all patient populations.

Source page: https://510kreport.com/device/K011918
Methodology: https://510kreport.com/methodology