# K143108: HealthGuard-15

- Pathway: 510(k) (Traditional)
- Applicant: Futrex, Inc.
- Decided: Mar 27, 2015 after 149 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). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063008: Health Check Kiosk, Xperex Corporation (2007) Summary page 4.
- K121932: Hem-7200-Z (BP742), Omron Healthcare, Inc. (2012) Summary page 4.
- K963271: Futrex-6100/XL, Futrex, Inc. (1998) Summary page 4.

## Indications for use
The HealthGuard-15 is a non-invasive screening device intended for use in corporate wellness facilities and in health/fitness clubs. It is not for use in medical facilities such as hospitals or doctor’s offices. This device measures systolic and diastolic blood pressure, heart rate, percent body fat and weight. It is operated by the client supplied PC computer. The device is intended for users eighteen years and older.

Source page: https://510kreport.com/device/K143108
Methodology: https://510kreport.com/methodology