# K071433: SMS Glucose Control, Model 2120059

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Medical Supplies
- Decided: Jun 28, 2007 after 36 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945887 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031260: Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System, Models 11001, 16000, and 16005, Abbott Diabetes Care, Inc. (2003) Summary page 1.
- K060481: Liberty Glucose Control Solution, Liberty Healthcare Group, Inc. (2006) Summary page 1.

## Indications for use
For in vitro diagnostic use (i.e. for external use only) by healthcare professionals and in the home by people with diabetes mellitus to assess the performance of the TheraSense FreeStyle Blood Glucose System.

Source page: https://510kreport.com/device/K071433
Methodology: https://510kreport.com/methodology