Cleared Special

K263422 - Mint ACE Pump

K263422 is an FDA 510(k) clearance for Mint ACE Pump, manufactured by Beta Bionics, Inc.. The device is a Class 2 Chemistry device with product code QFG cleared through the Special 510(k) pathway after a 26-day FDA review.

K263422 · Beta Bionics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
26d
Days
Class 2
Risk

K263422 is an FDA 510(k) clearance for the Mint ACE Pump. Classified as Alternate Controller Enabled Insulin Infusion Pump (product code QFG), Class II - Special Controls.

Submitted by Beta Bionics, Inc. (Irvine, US). The FDA issued a Cleared decision on October 21, 2026 after a review of 26 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 - K263422

510(k) Number K263422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2026
Decision Date October 21, 2026
Days to Decision 26 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
63d faster than avg
Panel avg: 89d · This submission: 26d
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 K263422.
Mint ACE Pump
K260001 · Beta Bionics, Inc. · Sep 2026
twiist Automated Insulin Delivery (AID) System
K261672 · Deka Research and Development · Jun 2026
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
K263422 · Mint ACE Pump
Download PDF FDA Summary Beta Bionics, Inc.