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THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K260001

510(k) cleared

Mint ACE Pump

Beta Bionics, Inc. · Sep 11, 2026 · K260001 · In the directory

FDA cleared the Mint ACE Pump from Beta Bionics, Inc. on Sep 11, 2026 under K260001, a traditional 510(k). The device falls under product code QFG, Alternate Controller Enabled Insulin Infusion Pump, regulated at 21 CFR 880.5730 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jan 2, 2026. The decision came 252 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beta Bionics, Inc. has 3 other decisions in the tracker over the last 12 months: K262763 (iLet Dosing Decision Software), K253976 (iLet ACE Pump), K252770 (iLet ACE Pump).

Questions & Answers

What did FDA clear under K260001?

K260001 is the FDA 510(k) for Mint ACE Pump, submitted by Beta Bionics, Inc.. FDA's decision date was Sep 11, 2026, under product code QFG (Alternate Controller Enabled Insulin Infusion Pump).

Who makes the Mint ACE Pump?

Beta Bionics, Inc., based in Irvine, CA, is the applicant of record for K260001. The company is listed in the MedDevice Startups directory.

How long did the K260001 review take?

FDA received the submission on Jan 2, 2026 and issued its decision on Sep 11, 2026, 252 days later.

← All decisions in September 2026

Sources

In the startup directory

Beta Bionics

Diabetes & Metabolic · Irvine, CA