# K113007: Bionime Diabetes Management System VI.0

- Pathway: 510(k) (Traditional)
- Applicant: Bionime Corporation
- Decided: Feb 27, 2012 after 143 days
- Product code: JQP (Calculator/Data Processing Module, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2100
- 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 K091820 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091820: Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes Management System, Bayer Healthcare (2009) Summary page 2.

## Most influential descendants
- K133522: Rightest Diabetes Management Software and Adapter (Existing Cleared K113007),Rightest New Adapters-3,GE Diabetes Managem (2014), 0 descendants of its own

## Indications for use
The Bionime Diabetes Management System is an over-the-counter software system for use by Health Care Professionals and Patients with diabetes as an aid for managing diabetes. User(s) can transfer blood glucose readings from Rightesto Glucose meter(s) to a personal computer for the purpose of viewing, analyzing and printing the glucose readings, as well as to backup and to recover users' profile and data. The Bionime Diabetes Management System is not intended to provide treatment decisions, nor should it substitute professional opinion. All medical diagnoses and treatment plans should be performed by a licensed healthcare professional.

Source page: https://510kreport.com/device/K113007
Methodology: https://510kreport.com/methodology