Cleared Special

K201214 - t:slim X2 Insulin Pump with Interoperab...

K201214 is the FDA 510(k) clearance for t:slim X2 Insulin Pump with Interoperab... by Tandem Diabetes Care, Inc.. It is a Class 2 Chemistry device (product code QFG) cleared through the Special 510(k) pathway after a 30-day FDA review.

K201214 · Tandem Diabetes Care, Inc. · Chemistry device
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Jun 2020
Decision
30d
Days
Class 2
Risk

K201214 is an FDA 510(k) clearance for the t:slim X2 Insulin Pump with Interoperable Technology. Classified as Alternate Controller Enabled Insulin Infusion Pump (product code QFG), Class II - Special Controls.

Submitted by Tandem Diabetes Care, Inc. (San Diego, US). The FDA issued a Cleared decision on June 4, 2020 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5730 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Tandem Diabetes Care, Inc. devices

Submission Details

510(k) Number K201214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2020
Decision Date June 04, 2020
Days to Decision 30 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 88d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QFG Alternate Controller Enabled Insulin Infusion Pump
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - QFG Alternate Controller Enabled Insulin Infusion Pump

All 26
Devices cleared under the same product code (QFG) and FDA review panel - the closest regulatory comparables to K201214.
iLet® ACE Pump
K223846 · Beta Bionics, Inc. · May 2023
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)
K203234 · Tandem Diabetes Care, Inc. · Feb 2022
Omnipod 5 ACE Pump (Pod)
K203768 · Insulet Corporation · Jan 2022
Omnipod DASH Insulin Management System with interoperable technology
K191679 · Insulet Corporation · Sep 2019
t:slim X2 insulin pump with interoperable technology
DEN180058 · Tandem Diabetes Care, Inc. · Feb 2019