Cleared Special

K233044 - Tandem Mobi insulin pump with interoperable technology

K233044 is an FDA 510(k) clearance for Tandem Mobi insulin pump with interoper..., manufactured by Tandem Diabetes Care, Inc.. The device is a Class 2 Chemistry device with product code QFG cleared through the Special 510(k) pathway after a 10-day FDA review.

K233044 · Tandem Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K233044

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
79d faster than avg
Panel avg: 89d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

QFG Device Classification - Class 2, Special Controls

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 29
Devices cleared under the same product code (QFG) and FDA review panel - the closest regulatory comparables to K233044.
Inessa System
K230545 · Triple Jump Israel , Ltd. · Dec 2023
t:slim X2 Insulin Pump with Interoperable Technology
K232380 · Tandem Diabetes Care, Inc. · Nov 2023
Omnipod 5 ACE Pump
K231826 · Insulet Corporation · Oct 2023
Accu-Chek Solo micropump system with interoperable technology
K213134 · Roche Diabetes Care GmbH · Aug 2023
DEKA ACE Pump System
K213536 · Deka Research and Development · Jul 2023
Tandem Mobi Insulin Pump with Interoperable Technology
K223213 · Tandem Diabetes Care, Inc. · Jul 2023
K233044 · Tandem Mobi insulin pump with interoperable technology
Download PDF FDA Summary Tandem Diabetes Care,…