# K082486: Glucofacts Express Diabetes Management Software

- Pathway: 510(k) (Special)
- Applicant: Bayer Healthcare, LLC
- Decided: Oct 8, 2008 after 41 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 K861844 (1986). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024234: Ascensia Glucofacts; Ascensia Glucofacts Professional, Bayer Corp. (2003) Summary page 1.

## Most influential descendants
- K122142: Glooko Logbook Charts (2012), 3 descendants of its own
- K130886: Glooko Device System for Glooko Logbook+ Application (2013), 2 descendants of its own
- K141862: HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart Cable (2014), 0 descendants of its own
- K132272: Glooko Device System for Glooko Application (2013), 0 descendants of its own
- K093930: Didget World Reports (2010), 0 descendants of its own

## Indications for use
GLUGOFACTS ® Express Diabetes Management Software is an over-the-counter software program for use by persons with diabetes in the home and by healthcare professionals in healthcare facilities to assist with transferring blood glucose data from a blood glucose monitor to a personal computer to allow reviewing and analyzing the data to support effective diabetes management.

Source page: https://510kreport.com/device/K082486
Methodology: https://510kreport.com/methodology