# K111210: T:Slim (TM) Insulin Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Nov 9, 2011 after 194 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K901588 (1990). 10 ancestors in all.
9 later devices descend from it; 2 cite it directly.
3 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990801: Minimed 508 Insulin Pump, Medtronic Minimed (1999) Summary page 1.
- K071613: Amigo Insulin Pump, Nipro Diabetes Systems, Inc. (2007) Summary page 1.

## Most influential descendants
- K133593: T:Slim Insulin Delivery System (2014), 8 descendants of its own
- K141758: T:Slim Insulin Delivery System (2014), 7 descendants of its own
- K160056: t:slim Insulin Delivery System (2016), 4 descendants of its own
- K240158: Modular Medical MODD1 Insulin Delivery System (2024), 2 descendants of its own
- K143189: t:flex Insulin Delivery System (2015), 2 descendants of its own

## Recalls of this device
- Jan 10, 2014 · Class I · Z-0827-2014: Specific lots of insulin cartridges that are used with the T:slim Insulin Pump may be at risk for leaking. A cartridge leak could result in the device delivering too much or too little insulin, which 

## Indications for use
The t:slim Insulin Delivery System is intended 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/K111210
Methodology: https://510kreport.com/methodology