# K091815: Supercheck 1 Blood Glucose Monitoring System, Model 6268

- Pathway: 510(k) (Traditional)
- Applicant: Biotest Medical Corp.
- Decided: Nov 16, 2009 after 151 days
- Product code: NBW (System, Test, Blood Glucose, Over The Counter)
- 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
Longest line of descent: 3 generations back to K042005 (2004). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073118: Prodigy Voice Blood Glucose Monitoring System, Diagnostic Devices, Inc. (2008) Summary page 1.

## Most influential descendants
- K100560: Easy Talk Blood Glucose Monitoring System Model: 6277 (2010), 1 descendant of its own
- K093764: SOLOV2 Blood Glucose Monitoring System (2010), 1 descendant of its own
- K133509: Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose Monitoring System,Smartest Persona II Bloo (2014), 0 descendants of its own
- K123559: Solusmobile Blood Glucose Managment System (2013), 0 descendants of its own
- K122525: Smartest Glucowise Blood Glucose Monitoring System, and Smartest Glucoswise Multi Blood Glucose Monitoring System (2013), 0 descendants of its own

## Indications for use
The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and 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, nor for use with neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains a speaking function that provides audible test results for users with low vision.

Source page: https://510kreport.com/device/K091815
Methodology: https://510kreport.com/methodology