# K113402: Solohealth Station

- Pathway: 510(k) (Traditional)
- Applicant: Solohealth, Inc.
- Decided: May 30, 2012 after 195 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
Longest line of descent: 8 generations back to K910772 (1991). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040562: Lifeclinic, Model 2400, Lifeclinic International, Inc. (2004) Summary page 6.
- K093389: Csi Model 5K Managed Health System Kiosk, Computerized Screening, Inc. (2009) Summary page 6.
- K063008: Health Check Kiosk, Xperex Corporation (2007) Summary page 6.

## Indications for use
The SoloHealth Station is intended to be used by the general public so that a user can measure his/her own blood pressure and pulse rate and his/her own weight. Additionally, the SoloHealth Station is intended to screen adults for clarity of central vision. SoloHealth Station does not provide a general screening of visual function and does not provide a diagnosis of eye health or other disease. The SoloHealth Station only screens clarity of central vision. Users should consult their personal physicians if they have concerns regarding their eyesight.

Source page: https://510kreport.com/device/K113402
Methodology: https://510kreport.com/methodology