# K130657: Linkdr 2.0 Diabetes Management Software

- Pathway: 510(k) (Traditional)
- Applicant: All Medicus Co., Ltd.
- Decided: Jul 15, 2013 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: 1 generation back to K984527 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984527: IN Touch Diabetes Management Software, Lifescan, Inc. (1999) Summary page 1.

## Indications for use
The LinkDr 2.0 Diabetes Management Software is a PC-based software intended for use in home and professional settings to help people with diabetes and their healthcare professionals in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to compatible All Medicus brand blood glucose monitoring systems such as the Glucoflr Supersensor blood glucose meter, GlucoDr Plus blood glucose meter and GlucoDr auto blood glucose meter.

Source page: https://510kreport.com/device/K130657
Methodology: https://510kreport.com/methodology