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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 / K262763

510(k) cleared

iLet Dosing Decision Software

Beta Bionics, Inc. · Sep 11, 2026 · K262763 · In the directory

FDA cleared the iLet Dosing Decision Software from Beta Bionics, Inc. on Sep 11, 2026 under K262763, a traditional 510(k). The device falls under product code QJI, Interoperable Automated Glycemic Controller, regulated at 21 CFR 862.1356 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Aug 4, 2026. The decision came 38 days later, inside the 90 FDA-day goal for a 510(k).

Beta Bionics, Inc. has 3 other decisions in the tracker over the last 12 months: K260001 (Mint ACE Pump), K253976 (iLet ACE Pump), K252770 (iLet ACE Pump).

Questions & Answers

What did FDA clear under K262763?

K262763 is the FDA 510(k) for iLet Dosing Decision Software, submitted by Beta Bionics, Inc.. FDA's decision date was Sep 11, 2026, under product code QJI (Interoperable Automated Glycemic Controller).

Who makes the iLet Dosing Decision Software?

Beta Bionics, Inc., based in Irvine, CA, is the applicant of record for K262763. The company is listed in the MedDevice Startups directory.

How long did the K262763 review take?

FDA received the submission on Aug 4, 2026 and issued its decision on Sep 11, 2026, 38 days later.

← All decisions in September 2026

Sources

In the startup directory

Beta Bionics

Diabetes & Metabolic · Irvine, CA