# K030105: Anesthesia Monitor; Bedside Monitor, Series BSM-5130A

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden America, Inc.
- Decided: Mar 4, 2003 after 50 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: 3 generations back to K951127 (1995). 6 ancestors in all.
14 later devices descend from it; 2 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)
- K001693: Life Scope P, Model BSM-4100 Series, Nihon Kohden America, Inc. (2000)
- K020046: Multigas Unit, Model AG-920RA, Nihon Kohden America, Inc. (2002) Summary page 2.

## Most influential descendants
- K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series (2008), 11 descendants of its own
- 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

## Indications for use
The series of device are 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) noninvasive blood pressure (NIBP) invasive blood pressure (IBP), body temperature, Cardiac Output (CO ), oxygen concentration (FiO2), carbon dioxide concentration (COz and EtCO2),and respiratory rate, C O 2 and EtCOZ,respiratory rate and inspired and expired anesthetic agents and anesthetic gases including N20, Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane. 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 including adults, children and infants. The ECAPS 12 interpretive ECG software program of the device is limited for use with patients age 3 years to adult. The interpretation is intended to provide an assessment of ECG waveform rhythm and morphology to assist the physician in diagnosis and is not intended as the sole basis for diagnosis. All assessments provided by the interpretation program are recommended for review by qualified physicians trained in electrocardiography.

Source page: https://510kreport.com/device/K030105
Methodology: https://510kreport.com/methodology