# K992684: Freestyle Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Jan 14, 2000 after 157 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945887 (1995). 9 ancestors in all.
33 later devices descend from it; 8 cite it directly.
3 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970707: Elect II Blood Glucose Monitoring System, Selfcare, Inc. (1997) Summary page 1.
- K930979: Accu-Chek Advantage Blood Glucose System, Boehringer Mannheim Corp. (1993) Summary page 1.
- K980731: Accu-Chek Comfort Curve Test Strips, Boehringer Mannheim Corp. (1998) Summary page 1.
- K982002: Accu-Chek Comfort Curve Test Strip, Boehringer Mannheim Corp. (1998) Summary page 1.
- K982076: Amira Medical Atlast Blood Glucose Monitoring System, Amira Medical, Inc. (1998) Summary page 1.

## 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
- 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

## Recalls of this device
- Apr 24, 2008 · Not classified · Z-1813-2008: Flaws in strip voltage continuity may result in frequency of an Error 3 ("Er3") message display and unreadable strips. This issue has the potential for creating a delay in generating blood glucose res
- May 22, 2006 · Not classified · Z-1307-06: The products may encounter display problem, 'Er 4' message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid

## Indications for use
The TheraSense Inc. FreeStyleTM Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh whole capillary blood. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The FreeStyle System is intended for use outside the body (in vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates (newborns) or arterial blood. The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger or arm.

Source page: https://510kreport.com/device/K992684
Methodology: https://510kreport.com/methodology