# K122142: Glooko Logbook Charts

- Pathway: 510(k) (Traditional)
- Applicant: Glooko, Inc.
- Decided: Dec 21, 2012 after 155 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 K861844 (1986). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082486: Glucofacts Express Diabetes Management Software, Bayer Healthcare, LLC (2008) Summary page 1.

## Most influential descendants
- 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 Glooko device system for the Glooko Logbook Application and Glooko Logbook Charts are data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for the Glooko Logbook Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their iPhone operating system platform. The Glooko device system for the Glooko Logbook Application and Glooko Logbook Charts are not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

Source page: https://510kreport.com/device/K122142
Methodology: https://510kreport.com/methodology