# K160056: t:slim Insulin Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Jul 25, 2016 after 195 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.
4 later devices descend from it; 2 cite it directly.
3 of 18 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
- K240158: Modular Medical MODD1 Insulin Delivery System (2024), 2 descendants of its own
- K253534: Pivot Insulin Delivery System (2026), 1 descendant of its own
- K262153: Pivot Insulin Delivery System (2026), 0 descendants 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: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.

Source page: https://510kreport.com/device/K160056
Methodology: https://510kreport.com/methodology