# K162080: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Oct 25, 2016 after 90 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: 10 generations back to K901588 (1990). 28 ancestors in all.
No later device cites it as a predicate yet.
6 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160482: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater, Tandem Diabetes Care, Inc. (2016). Our reading of the summary gave K160428, FDA’s number for Certex Spinal Fixation System (X-Spine Systems, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Tandem Diabetes Care, Inc. t:slim® Insulin Delivery System, t:flex®…”. Summary page 4.
- K160056: t:slim Insulin Delivery System, Tandem Diabetes Care, Inc. (2016) Summary page 4.

## 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 6 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/K162080
Methodology: https://510kreport.com/methodology