# K122361: T:Connect Data Management System

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Feb 22, 2013 after 203 days
- Product code: OUG (Medical Device Data System)
- Device class: 1
- Regulation: 21 CFR 880.6310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K864318 (1987). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032164: Diabetes Data Management System (DDMS), Model 7333, Medtronic Minimed (2003) Summary page 1.
- K101806: Aidera Diasend System, Aidera AB (2010) Summary page 1.

## Indications for use
The t:connect Diabetes Management Application is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their caregivers, and their healthcare providers in home and clinical settings. The t:connect Application supports diabetes management through the display and analysis of information downloaded from Tandem Diabetes Care insulin pumps and specified blood glucose meters.

Source page: https://510kreport.com/device/K122361
Methodology: https://510kreport.com/methodology