# K143189: t:flex Insulin Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Jan 9, 2015 after 65 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K901588 (1990). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
3 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141758: T:Slim Insulin Delivery System, Tandem Diabetes Care, Inc. (2014) Summary page 4.

## Most influential descendants
- K160482: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (2016), 1 descendant of its own
- K162080: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (2016), 0 descendants of its own

## Indications for use
The t:flex™ Insulin Delivery System is indicated for the subcutaneous delivery of insulin at set and variable rates, for the management of diabetes mellitus in persons requiring insulin, for individuals 12 years of age and greater.

Source page: https://510kreport.com/device/K143189
Methodology: https://510kreport.com/methodology