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FDA 510(k)

Basal-IQ Technology

K-Number: K193483 · 2020-02-28

ApplicantTandem Diabetes Care, Inc.
Decision Date2020-02-28
Product CodeQJS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Basal-IQ Technology 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 2020-02-28 under 510(k) number K193483. The device is classified under product code QJS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Basal-IQ Technology?

Basal-IQ Technology is a medical device that received FDA 510(k) clearance on 2020-02-28. The listed applicant is Tandem Diabetes Care, Inc.. The 510(k) number is K193483.

When did Basal-IQ Technology receive FDA 510(k) clearance?

Basal-IQ Technology received FDA 510(k) clearance on 2020-02-28, under 510(k) number K193483.

Who is the listed applicant for Basal-IQ Technology?

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 Basal-IQ Technology?

The FDA product code for Basal-IQ Technology is QJS.

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 DiabetesCOMPLETED

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 →

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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