# K072369: Evolution Blood Glucose Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Hmd Biomedical, LLC
- Decided: Mar 21, 2008 after 211 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: 2 generations back to K950727 (1995). 3 ancestors in all.
21 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021819: One Touch Ultrasmart Blood Glucose Monitoring System, Lifescan, Inc. (2002) Summary page 1.

## Most influential descendants
- K081703: Myglucohealth Glucose Monitoring Systems (2009), 10 descendants of its own
- K113105: Tempusic Patient Monitor (2011), 8 descendants of its own
- K152124: Tempus IC2 (2015), 7 descendants of its own
- K152645: Dictum Health (2016), 6 descendants of its own
- K170798: Dictum Health (2017), 5 descendants of its own

## Indications for use
The EvolutionTM Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in whole blood from the fingertip, ventral palm, dosal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals as an aid in the management of diabetes. EvolutionTM Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady- state times when glucose is not changing rapidly.

Source page: https://510kreport.com/device/K072369
Methodology: https://510kreport.com/methodology