Cleared Traditional

K240309 - Tandem Mobi insulin pump with interoper...

K240309 is the FDA 510(k) clearance for Tandem Mobi insulin pump with interoper... by Tandem Diabetes Care, Inc.. It is a Class 2 Chemistry device (product code QFG) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K240309 · Tandem Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Mar 2024
Decision
48d
Days
Class 2
Risk

K240309 is an FDA 510(k) clearance for the Tandem Mobi 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 March 21, 2024 after a review of 48 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tandem Diabetes Care, Inc. devices

Submission Details

510(k) Number K240309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2024
Decision Date March 21, 2024
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
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 K240309.
embecta Insulin Delivery System
K234027 · Embecta Medical I, LLC · Aug 2024
Tandem Mobi Insulin Pump with interoperable technology
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DEKA ACE Pump System
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Inessa System
K230545 · Triple Jump Israel , Ltd. · Dec 2023
t:slim X2 Insulin Pump with Interoperable Technology
K232380 · Tandem Diabetes Care, Inc. · Nov 2023