# K160482: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Jul 13, 2016 after 142 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: 9 generations back to K901588 (1990). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 28 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.
- K143189: t:flex Insulin Delivery System, Tandem Diabetes Care, Inc. (2015) Summary page 4.
- K111386: Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (PSS), Smiths Medical MD, Inc. (2011) Summary page 4.

## Most influential descendants
- 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:slim® 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. The device is indicated for use with NovoLog or Humalog U-100 insulin. 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. The device is indicated for use with NovoLog or Humalog U-100 insulin. The Tandem® Device Updater™ System consists of software which allows for communication between a computer and a t:slim® or t:flex™ Insulin Delivery System. It allows for remote software installation and update of a Tandem Insulin Delivery System.

Source page: https://510kreport.com/device/K160482
Methodology: https://510kreport.com/methodology