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FDA 510(k)

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)

K-Number: K203234 · 2022-02-15

ApplicantTandem Diabetes Care, Inc.
Decision Date2022-02-15
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) is a medical device manufactured by Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2022-02-15 under approval number K203234. 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 (with t:connect mobile app)?

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) is a medical device that received FDA 510(k) clearance on 2022-02-15. It is manufactured by Tandem Diabetes Care, Inc.. The 510(k) number is K203234.

When was t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) approved by the FDA?

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) received FDA 510(k) clearance on 2022-02-15, under approval number K203234.

What company makes t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)?

t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) is manufactured by Tandem Diabetes Care, Inc..

What is the FDA product code for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)?

The FDA product code for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) is QFG.

Related Clinical Trials

NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING 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 NCT07571538 VisionApp - Ghosting RECRUITING NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING

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. K203768Omnipod 5 ACE Pump (Pod)Insulet Corporation K230545Inessa SystemTriple Jump Israel , Ltd. K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc.

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.

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