Cleared Traditional

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

K203234 · Tandem Diabetes Care, Inc. · Chemistry

Feb 2022

Decision

469d

Days

Class 2

Risk

About This 510(k) Submission

K203234 is an FDA 510(k) clearance for the t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app), a Alternate Controller Enabled Insulin Infusion Pump (Class II — Special Controls, product code QFG), submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on February 15, 2022, 469 days after receiving the submission on November 3, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 880.5730.

Submission Details

510(k) Number	K203234 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2020
Decision Date	February 15, 2022
Days to Decision	469 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QFG — Alternate Controller Enabled Insulin Infusion Pump
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5730
Definition	An Alternate Controller Enabled Insulin Infusion Pump (ace Insulin Pump) Is A Device Intended For The Infusion Of Insulin Into A Patient. The Ace Insulin Pump May Include Basal And Bolus Drug Delivery At Set Or Variable Rates. Ace Insulin Pumps Are Designed To Reliably And Securely Communicate With External Devices, Such As Automated Insulin Dosing Systems, To Allow Insulin Delivery Commands To Be Received, Executed, And Confirmed. Ace Insulin Pumps Are Intended To Be Used Both Alone And In Conjunction With Digitally Connected Medical Devices For The Purpose Of Insulin Delivery.