# DEN180058: t:slim X2 insulin pump with interoperable technology

- Pathway: De Novo (Direct)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Feb 14, 2019 after 108 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 3 cite it directly.
8 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K201214: t:slim X2 Insulin Pump with Interoperable Technology (2020), 17 descendants of its own
- K203234: t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) (2022), 12 descendants of its own
- K232380: t:slim X2 Insulin Pump with Interoperable Technology (2023), 6 descendants of its own
- K191679: Omnipod DASH Insulin Management System with interoperable technology (2019), 6 descendants of its own
- K251032: MiniMed 780G insulin pump (2025), 4 descendants of its own

## Indications for use
The t:slim X2 insulin pump with interoperable technology (the Pump) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use with NovoLog or Humalog U-100 insulin. The Pump is indicated for use in individuals 6 years of age and greater.

Source page: https://510kreport.com/device/DEN180058
Methodology: https://510kreport.com/methodology