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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K253976

510(k) cleared

iLet ACE Pump

Beta Bionics, Inc. · Apr 30, 2026 · K253976

FDA cleared the iLet ACE Pump from Beta Bionics, Inc. on Apr 30, 2026 under K253976, 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 Dec 12, 2025. The decision came 139 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beta Bionics, Inc. has one other decision in the tracker over the last 12 months: K252770 (iLet ACE Pump).

Questions & Answers

What did FDA clear under K253976?

K253976 is the FDA 510(k) for iLet ACE Pump, submitted by Beta Bionics, Inc.. FDA's decision date was Apr 30, 2026, under product code QFG (Alternate Controller Enabled Insulin Infusion Pump).

Who makes the iLet ACE Pump?

Beta Bionics, Inc., based in Concord, MA, is the applicant of record for K253976.

How long did the K253976 review take?

FDA received the submission on Dec 12, 2025 and issued its decision on Apr 30, 2026, 139 days later.

← All decisions in April 2026

Sources