Cleared Traditional

Basal-IQ Technology

K193483 · Tandem Diabetes Care, Inc. · Chemistry
Feb 2020
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K193483 is an FDA 510(k) clearance for the Basal-IQ Technology, a Interoperable Automated Glycemic Controller, Insulin Suspend (Class II — Special Controls, product code QJS), submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on February 28, 2020, 73 days after receiving the submission on December 17, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1356.

Submission Details

510(k) Number K193483 FDA.gov
FDA Decision Cleared SESE
Date Received December 17, 2019
Decision Date February 28, 2020
Days to Decision 73 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code QJS — Interoperable Automated Glycemic Controller, Insulin Suspend
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1356
Definition An Interoperable Automated Glycemic Controller, Insulin Suspend, Is A Device That Temporarily Suspend And Resumes Insulin Infusion From A Connected Infusion Pump Based On Specified Thresholds And Input Glucose Levels. Interoperable Automated Glycemic Controllers, Insulin Suspend, Are Designed To Reliably And Securely Communicate With Digitally Connected Devices To Allow Insulin Delivery Suspension And Resumption Commands To Be Sent, Received, Executed, And Confirmed. Interoperable Automated Glycemic Controllers, Insulin Suspend, Are Intended To Be Used In Conjunction With Digitally Connected Devices For The Purpose Of Maintaining Glycemic Control.