# K092638: Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Jun 15, 2010 after 292 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K945887 (1995). 28 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992684: Freestyle Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2000) Summary page 1.
- K000582: Freestyle Blood Glucose Monitoring System, Cat NO 11001, Abbott Diabetes Care, Inc. (2000) Summary page 1.
- K012014: Modification to Blood Glucose Monitoring System, Abbott Diabetes Care, Inc. (2001) Summary page 1.
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005, Abbott Diabetes Care, Inc. (2003) Summary page 1.
- K051839: Free-Style Freedom Blood Glucose Monitoring System, Model 11001, Abbott Diabetes Care, Inc. (2006) Summary page 1.

## Most influential descendants
- K112638: Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips (2012), 3 descendants of its own
- K122435: Nova One Blood Glucose Monitor (2012), 1 descendant of its own
- K131013: Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System (2013), 0 descendants of its own
- K122688: Nova Max Mini Blood Glucose and B-Ketone Monitor (2013), 0 descendants of its own

## Recalls of this device
- Feb 19, 2014 · Class I · Z-1212-2014: Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or err
- Feb 19, 2014 · Class I · Z-1211-2014: Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or err

## Indications for use
The FreeStyle 3 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood. The FreeStyle 5 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood. The FreeStyle Flash Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood. The FreeStyle Freedom Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in capillary whole blood from the finger, upper arm and palm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

Source page: https://510kreport.com/device/K092638
Methodology: https://510kreport.com/methodology