# K061328: Think Positive Diabetes Management System (T+Diabetes System)

- Pathway: 510(k) (Traditional)
- Applicant: E-San Limited
- Decided: Jun 13, 2006 after 32 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: 7 generations back to K864318 (1987). 14 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052343: E-San Bluetooth Cradle, E-San Limited (2005) Summary page 1.

## Most influential descendants
- K062377: Medapps Remote Patient Monitoring, Model MA 100 (2007), 20 descendants of its own
- K083862: Medapps 2.0 Remote Patient Monitoring System (2009), 12 descendants of its own
- K124000: Medapps 2.0 - Remote Patient Monitoring System (2013), 4 descendants of its own
- K112559: Medapps 2.0 Remote Patient Monitoring System (2011), 4 descendants of its own
- K093379: TCX-I-DV Remote Care Management System (2010), 4 descendants of its own

## Indications for use
The e-San Bluetooth Cradle is intended to be used by patients at home. It is physically connected to a LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and wirelessly sends the signals (via Bluetooth V1.2) to a Bluetooth enabled cellular phone such as the Nokia 6230. The e-San Bluetooth Cradle serves as the remote communication link between the LifeScan OneTouch® Ultra® Blood Glucose Monitoring System and a cellular telephone. The t+ Diabetes System enables users to store and display data on the cellular phone, and to send data from the cellular telephone to a remote database for storage and display via the internet.

Source page: https://510kreport.com/device/K061328
Methodology: https://510kreport.com/methodology