# K950727: One Touch Profile Complete Diabetes Tracking System

- Pathway: 510(k) (Traditional)
- Applicant: Lifescan, Inc.
- Decided: Jun 1, 1995 after 105 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.
75 later devices descend from it; 2 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## 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

Source page: https://510kreport.com/device/K950727
Methodology: https://510kreport.com/methodology