# K111932: Iglucose System

- Pathway: 510(k) (Traditional)
- Applicant: Positiveid Corporation
- Decided: Nov 10, 2011 after 125 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: 9 generations back to K864318 (1987). 27 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062377: Medapps Remote Patient Monitoring, Model MA 100, Medapps, Inc. (2007) Summary page 1.
- K080538: Ideal Life Pod (Model Ilp 0001), Ideal Life, Inc. (2008) Summary page 1.

## Most influential descendants
- K130676: Ambio Remote Health Monitoring System (2013), 1 descendant of its own
- K132148: S Health (2013), 0 descendants of its own

## Indications for use
The iglucose™ System collects and transmits stored data from a variety of FDA cleared blood glucose meters such as the LifeScan® OneTouch® and Home Diagnostics™ True™ monitoring systems to a secure database via wireless cellular technology. Subsequently, blood glucose data can then be reviewed through a web portal as an aid in supporting diabetes management. It is intended to be used in a home or health care facility settings. The iglucose™ System does not measure, interpret or make decisions on the data that it conveys, nor is it intended to provide automated treatment decisions, or to be used as a substitute for professional healthcare judgment. All medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.

Source page: https://510kreport.com/device/K111932
Methodology: https://510kreport.com/methodology