# K173589: Prizma

- Pathway: 510(k) (Traditional)
- Applicant: G-Medical Innovations, Ltd.
- Decided: Nov 30, 2018 after 375 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- 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 K962603 (1997). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170181: Prizma, G-Medical Innovations, Ltd. (2017) Summary page 4.
- K040178: Pulseox 5500 Finger Device, Pulseox 7500 Wristwatch Device, S.P.O. Medical Equipment, Ltd. (2004) Summary page 4.

## Indications for use
The Prizma device is indicated for home users to measure, record, display and/or transmit ECG one-lead data, heart rate, peripheral oxygen saturation, pulse rate and body temperature data. The device utilizes a mobile platform to initiate user actions (test, display and data transfer by email) through the mobile application. Intended population: adult patients.

Source page: https://510kreport.com/device/K173589
Methodology: https://510kreport.com/methodology