# K032749: Bedside Monitor, Model Opv-1500

- Pathway: 510(k) (Special)
- Applicant: Nihon Kohden America, Inc.
- Decided: Sep 16, 2003 after 11 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001693 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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)

## 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 ECG. The device is also intended to monitor heart rate, pulse rate, blood oxygen saturation (SpOz) noninvasive blood pressure (NIBP) 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. Waveforms, numeric data, trend graphs, and vital signs lists can be recorded manually or automatically on the optional recorder unit. Waveforms and parameter data from the monitor can be sent to a Cardiac Telemetry System, or to a Central Monitor via a Multiple Patient Receiver and transmitter. The device will be available for use by medical personnel on all patient populations.

Source page: https://510kreport.com/device/K032749
Methodology: https://510kreport.com/methodology