# K000582: Freestyle Blood Glucose Monitoring System, Cat NO 11001

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Dec 5, 2000 after 287 days
- Product code: LFR (Glucose Dehydrogenase, 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.
23 later devices descend from it; 5 cite it directly.
3 of 24 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
- 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
- K050500: Freestyle 600 Blood Glucose Monitoring System (2005), 12 descendants of its own
- K051839: Free-Style Freedom Blood Glucose Monitoring System, Model 11001 (2006), 10 descendants of its own
- K092638: Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23 (2010), 4 descendants of its own

Source page: https://510kreport.com/device/K000582
Methodology: https://510kreport.com/methodology