t:slim X2 Insulin Pump with Basal-IQ Technology

FDA PMAFDA 510(k)

Class III (US FDA PMA)

PMA P180008510(k) K193483

by Tandem Diabetes Care, Inc.

Identity

Trade Name: t:slim X2 Insulin Pump with Basal-IQ Technology FDA PMA
Generic Name: Automated insulin dosing , threshold suspend FDA PMA

Identifiers

PMA Number: P180008 FDA PMA
510(k) Number: K193483 FDA PMA
FDA Product Code: QJS FDA PMA

Classification

Device Class: Class II FDA PMA
Legislation / Framework: 21 CFR Part 862.1356 FDA PMA
Regulation Number: 862.1356 FDA PMA
Advisory Committee: Clinical Chemistry FDA PMA
FDA Decision: SESE Substantially Equivalent FDA PMA

The t:slim X2 Insulin Pump with Basal-IQ Technology is an automated insulin dosing system designed for the subcutaneous delivery of insulin in individuals 6 years of age and older. The system integrates with compatible continuous glucose monitors to suspend insulin delivery automatically based on sensor readings, assisting in the management of diabetes mellitus.

This device is intended for single-patient use and requires a prescription for operation. It is indicated for use with U-100 NovoLog or Humalog insulin and functions as an interoperable automated glycemic controller. The system has received FDA 510(k) and PMA authorizations for its clinical application.

Frequently asked questions

What is the primary function of the Basal-IQ technology?

The Basal-IQ technology is designed to automatically suspend insulin delivery based on continuous glucose monitor sensor readings to help manage diabetes.

Who is the intended user for this insulin pump system?

The system is indicated for use by individuals 6 years of age and older who require insulin for the management of diabetes mellitus.

Which types of insulin are compatible with this device?

The t:slim X2 Insulin Pump with Basal-IQ Technology is indicated for use with U-100 NovoLog or Humalog insulin.

Does this device require a prescription?

Yes, the system is intended for single-patient use and requires a prescription from a healthcare provider.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: t:slim X2 Insulin Pump - Tandem Diabetes Care, t:slim X2™ Insulin Pump with Control-IQ™ Technology, t:slim X2 insulin pump with Basal-IQ Technology, Control-IQ+ Technology for Automated Insulin Delivery, Air Liquide Healthcare launches the Tandem Diabetes Care t ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K193483	Class III	Active
FDA PMA	United States	FDA_PMA	P180008	Class III	Active

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Manufacturer

Manufacturer: Tandem Diabetes Care, Inc.

Sources (2)

FDA PMA P180008 37 fields · synced Oct 6, 2026
FDA 510(k) K193483 1 fields · synced May 18, 2026