# K994433: Connect Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: May 5, 2000 after 127 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952279 (1995). 1 ancestor in all.
39 later devices descend from it; 3 cite it directly.
3 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952279: Precision Link Blood Glucose Data Management System, Medisense, Inc. (1995) Summary page 2.

## Most influential descendants
- 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
- K050500: Freestyle 600 Blood Glucose Monitoring System (2005), 12 descendants of its own

## Recalls of this device
- Aug 30, 2005 · Not classified · Z-1594-05: Downloadable software obtained from the firm's website displays user data (including but not limited to insulin levels and pump statistics data) in a matter that may be misinterpreted and result in mi

## Indications for use
The TheraSense Inc. FreeStyle™ Connect Data Management System is intended for use in home and clinical settings to aid people with diabetes and health care professionals in the review, analysis, and evaluation of historical blood glucose test results to support an effective diabetes management program.

Source page: https://510kreport.com/device/K994433
Methodology: https://510kreport.com/methodology