# K040086: Health Buddy with Buddylink

- Pathway: 510(k) (Traditional)
- Applicant: Health Hero Network, Inc.
- Decided: Mar 10, 2004 after 54 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: 1 generation back to K950727 (1995). 4 ancestors in all.
47 later devices descend from it; 9 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993128: Healthbuddy with Device Connect [Glucose Meter], Health Hero Network, Inc. (1999) Summary page 1.
- K950727: One Touch Profile Complete Diabetes Tracking System, Lifescan, Inc. (1995) Summary page 2.
- K984527: IN Touch Diabetes Management Software, Lifescan, Inc. (1999) Summary page 1.
- K020184: Hommed Central Station, Hommed, LLC (2002) Summary page 1.

## Most influential descendants
- K042273: Modification to Health Buddy with Device Connectivity (2004), 45 descendants of its own
- K050567: Health Buddy Appliance (2005), 40 descendants of its own
- K060843: Modification to Health Buddy Appliance (2006), 39 descendants of its own
- K063612: Modification to Health Buddy Appliance (2006), 30 descendants of its own
- K080798: Intel Health Guide, Model: PHS6000 (2008), 25 descendants of its own

## Indications for use
Health Buddy® with Buddylink is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.

Source page: https://510kreport.com/device/K040086
Methodology: https://510kreport.com/methodology