# K230996: Pursuant Health Kiosk (G1.D5)

- Pathway: 510(k) (Traditional)
- Applicant: Pursuant Health
- Decided: Jan 4, 2024 after 272 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Pursuant Health Kiosk is intended to be used by the general public so that a user can measure their own blood pressure, pulse rate, and weight. Additionally, the kiosk can capture digital images of an adult user’s retina without the use of a mydriatic agent. It is not a diagnostic device and only furnishes retinal images that users can send to their personal physician or other healthcare professional.

Source page: https://510kreport.com/device/K230996
Methodology: https://510kreport.com/methodology