# K163459: Nihon Kohden Vital Sign Telemeter

- Pathway: 510(k) (Traditional)
- Applicant: Nihon Kohden Corporation
- Decided: Apr 4, 2017 after 116 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: 6 generations back to K951127 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series, Nihon Kohden America, Inc. (2008) Summary page 4.
- K153707: Nihon Kohden Vital Sign Telemeter, Nihon Kohden Corporation (2016) Summary page 4.

## Indications for use
The Nihon Kohden Vital Sign Telemeter GZ-140P is intended to monitor and transmit physiological data from a patient to a Nihon Kohden monitor via radiofrequency in the 802.11 band for continuous monitoring. GZ-140P transmits electrocardiogram (ECG), respiration data, blood oxygen saturation (SpO2) and non-invasive blood pressure (NIBP). The device may generate an audible and/or visible alarm when an arrhythmia exists, when a measured physiological rate falls outside preset limits, or when a technical error is detected. Furthermore, the device can be configured for use as a temporary simple monitor to display the patient’s vital signs on the device screen and generate alarms without transmitting the data to other Nihon Kohden monitor. The device is intended to be used by qualified medical personnel within a medical facility, such as hospital or clinic, on all patient populations including adult, neonate, infant, child, and adolescent subgroups, with the exception of NIBP measurement which is not intended for use on neonates.

Source page: https://510kreport.com/device/K163459
Methodology: https://510kreport.com/methodology