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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 the device name listed in this FDA 510(k) record. The listed applicant is Tandem Diabetes Care, Inc.. It received FDA 510(k) clearance on 2022-02-15 under 510(k) 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. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K203234.

When did t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) receive FDA 510(k) clearance?

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

Who is the listed applicant for t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)?

The FDA 510(k) record lists Tandem Diabetes Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05785832A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 DiabetesCOMPLETEDNCT06024928Automated Insulin Delivery (AID) for Basal Insulin Titration in Type 2 DiabetesCOMPLETEDNCT05014789Control-IQ Technology 2.0 Adult and Adolescent Feasibility StudyCOMPLETEDNCT07325461Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 DiabetesCOMPLETEDNCT06880835Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin DeliveryRECRUITINGNCT03288207Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood EnvironmentsRECRUITING

Other records listing Tandem Diabetes Care, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260429Control-IQ+ technologyK253074Tandem Mobi insulin pump with interoperable technologyK250792t:slim X2 insulin pump with interoperable technologyK251854SteadiSet infusion setK250798Control-IQ+ technologyK243823Control-IQ+ technology

View all 21 devices →

Related Devices (Code: QFG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and DevelopmentK253976iLet ACE PumpBeta Bionics, Inc.K253743MiniMed Flex pumpMedtronic Minimed, Inc.K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.K252770iLet ACE PumpBeta Bionics, 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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