# K993128: Healthbuddy with Device Connect [Glucose Meter]

- Pathway: 510(k) (Traditional)
- Applicant: Health Hero Network, Inc.
- Decided: Nov 23, 1999 after 64 days
- Product code: CGA (Glucose Oxidase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
48 later devices descend from it; 9 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) LifeScan ONE TOUCH Profile Diabetes Tracking System: named in the summary without a submission number
- (no number) LifeScan IN TOUCH Diabetes Management Software: named in the summary without a submission number

## Most influential descendants
- K040086: Health Buddy with Buddylink (2004), 47 descendants of its own
- 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

## Indications for use
Health Buddy with Device Connect [Glucose Meter] is indicated for use in non-clinical settings to collect and transmit historical blood glucose data to healthcare professionals to help support effective management of diabetes patients.

Source page: https://510kreport.com/device/K993128
Methodology: https://510kreport.com/methodology