Cleared Traditional

K203234 - t:slim X2 Insulin Pump with Interoperab...

K203234 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 Traditional 510(k) pathway after a 469-day FDA review.

K203234 · Tandem Diabetes Care, Inc. · Chemistry device
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Feb 2022
Decision
469d
Days
Class 2
Risk

K203234 is an FDA 510(k) clearance for the t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app). 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 February 15, 2022 after a review of 469 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5730 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Tandem Diabetes Care, Inc. devices

Submission Details

510(k) Number K203234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
381d slower than avg
Panel avg: 88d · This submission: 469d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K203234.
Tandem Mobi Insulin Pump with Interoperable Technology
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iLet® ACE Pump
K223846 · Beta Bionics, Inc. · May 2023
Omnipod 5 ACE Pump (Pod)
K203768 · Insulet Corporation · Jan 2022
t:slim X2 Insulin Pump with Interoperable Technology
K201214 · Tandem Diabetes Care, Inc. · Jun 2020
Omnipod DASH Insulin Management System with interoperable technology
K191679 · Insulet Corporation · Sep 2019