# K024234: Ascensia Glucofacts; Ascensia Glucofacts Professional

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jan 23, 2003 after 31 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: 1 generation back to K861844 (1986). 1 ancestor in all.
6 later devices descend from it; 1 cites 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)
- K861844: Glucofacts Data Management System, Miles Laboratories, Inc. (1986) Summary page 1.

## Most influential descendants
- K082486: Glucofacts Express Diabetes Management Software (2008), 5 descendants of its own
- 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

## Indications for use
The Ascensia wmGlucofacts and the Ascensia Win Glucofacts Professional software are accessories to the Ascensiam Blood Glucose monitoring systems. The Ascensia winGlucofacts and the Ascensia w"Glucofacts Professional software are Over-The Counter (OTC) devices used by persons with diabetes and by healthcare professionals for data transfer in the home and in healthcare facilities.

Source page: https://510kreport.com/device/K024234
Methodology: https://510kreport.com/methodology