Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

t:slim X2 insulin pump with interoperable technology

K-Number: K250792 · 2025-09-24

ApplicantTandem Diabetes Care, Inc.
Decision Date2025-09-24
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

t:slim X2 insulin pump with interoperable technology is a medical device manufactured by Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2025-09-24 under approval number K250792. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the t:slim X2 insulin pump with interoperable technology?

t:slim X2 insulin pump with interoperable technology is a medical device that received FDA 510(k) clearance on 2025-09-24. It is manufactured by Tandem Diabetes Care, Inc.. The 510(k) number is K250792.

When was t:slim X2 insulin pump with interoperable technology approved by the FDA?

t:slim X2 insulin pump with interoperable technology received FDA 510(k) clearance on 2025-09-24, under approval number K250792.

What company makes t:slim X2 insulin pump with interoperable technology?

t:slim X2 insulin pump with interoperable technology is manufactured by Tandem Diabetes Care, Inc..

What is the FDA product code for t:slim X2 insulin pump with interoperable technology?

The FDA product code for t:slim X2 insulin pump with interoperable technology is QFG.

Related Clinical Trials

NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT06124196 Wearable Technology to Evaluate Hyperglycemia and HRV in DMD RECRUITING NCT05785832 A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes COMPLETED NCT06024928 Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 Diabetes COMPLETED

Related PubMed Literature

PMID: 41964171 Journal of diabetes science and technology (2026)

Other Devices by Tandem Diabetes Care, Inc.

K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater K160056t:slim Insulin Delivery System K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater DEN190034Control-IQ Technology DEN180058t:slim X2 insulin pump with interoperable technology K200467Control-IQ Technology

View all 22 devices →

Related Devices (Code: QFG)

K191679Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation DEN180058t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. K203768Omnipod 5 ACE Pump (Pod)Insulet Corporation K230545Inessa SystemTriple Jump Israel , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑