# K132173: Family Healthware

- Pathway: 510(k) (Traditional)
- Applicant: Sanitas, Inc.
- Decided: May 30, 2014 after 319 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K864318 (1987). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123671: Wellaho Personalized Outpatient Management System, Sanitas, Inc. (2013) Summary page 4.

## Indications for use
Family Healthware™ is a self-administered, interactive Web-based tool that assesses familial risk for six diseases (coronary heart disease, stroke, diabetes, and colorectal, breast, and ovarian cancer) and provides personalized recommendations for lifestyle changes and screening.

Source page: https://510kreport.com/device/K132173
Methodology: https://510kreport.com/methodology