# K201214: t:slim X2 Insulin Pump with Interoperable Technology

- Pathway: 510(k) (Special)
- Applicant: Tandem Diabetes Care, Inc.
- Decided: Jun 4, 2020 after 30 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180058 (2019). 1 ancestor in all.
17 later devices descend from it; 2 cite it directly.
7 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180058: t:slim X2 insulin pump with interoperable technology, Tandem Diabetes Care, Inc. (2019) Summary page 4.

## Most influential descendants
- 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
- K251032: MiniMed 780G insulin pump (2025), 4 descendants of its own
- K223213: Tandem Mobi Insulin Pump with Interoperable Technology (2023), 4 descendants of its own
- K233044: Tandem Mobi insulin pump with interoperable technology (2023), 3 descendants of its own

## Recalls of this device
- Jul 16, 2026 · Class II · Z-3330-2026: A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a software issue preventing successful pairing of the t:slim application with Abbott FreeStyle Libre 3 Plus (FSL3P)
- Aug 5, 2025 · Class II · Z-0232-2026: A software defect in versions 7.9.0.1 and 7.10.1 of the pump software for Tandem t:slim X2 and version 7.9.0.1 of the Tandem Mobi pump with Control-IQ+ technology that are paired with a G7 sensor may 
- Jul 21, 2025 · Class I · Z-2343-2025: Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin whic

## 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/K201214
Methodology: https://510kreport.com/methodology