# K132272: Glooko Device System for Glooko Application

- Pathway: 510(k) (Special)
- Applicant: Glooko, Inc.
- Decided: Oct 17, 2013 after 87 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: 5 generations back to K861844 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130886: Glooko Device System for Glooko Logbook+ Application, Glooko, Inc. (2013) Summary page 4.

## Indications for use
The Glooko device system for Glooko Application is 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 Glooko Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their mobile devices running on Android Operating System. The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.

Source page: https://510kreport.com/device/K132272
Methodology: https://510kreport.com/methodology