# K952279: Precision Link Blood Glucose Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Medisense, Inc.
- Decided: Jun 14, 1995 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.
46 later devices descend from it; 3 cite it directly.
3 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K994433: Connect Data Management System (2000), 39 descendants of its own
- K012014: Modification to Blood Glucose Monitoring System (2001), 23 descendants of its own
- K020866: Freestyle Tracker Diabetes Management System (2002), 22 descendants of its own
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005 (2003), 18 descendants of its own
- K062434: Zero-Click Data Management System, Model 8000-01528 (2006), 14 descendants of its own

Source page: https://510kreport.com/device/K952279
Methodology: https://510kreport.com/methodology