Cleared Special

K233044 - Tandem Mobi insulin pump with interoperable technology (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233044 · Tandem Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
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Oct 2023
Decision
10d
Days
Class 2
Risk

K233044 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 October 5, 2023 after a review of 10 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 K233044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2023
Decision Date October 05, 2023
Days to Decision 10 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
78d faster than avg
Panel avg: 88d · This submission: 10d
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 K233044.
iLet ACE Pump
K253976 · Beta Bionics, Inc. · Apr 2026
MiniMed Flex pump
K253743 · Medtronic Minimed, Inc. · Mar 2026
MiniMed 780G Insulin Pump (MMT-1884)
K253470 · Medtronic Minimed, Inc. · Jan 2026
Tandem Mobi insulin pump with interoperable technology
K253074 · Tandem Diabetes Care, Inc. · Nov 2025
iLet ACE Pump
K252770 · Beta Bionics, Inc. · Sep 2025
t:slim X2 insulin pump with interoperable technology
K250792 · Tandem Diabetes Care, Inc. · Sep 2025