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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 / November 2025 / K250264

510(k) cleared

SugarBug (1.x)

Bench7, Inc. · Nov 7, 2025 · K250264

FDA cleared the SugarBug (1.x) from Bench7, Inc. on Nov 7, 2025 under K250264, a traditional 510(k). The device falls under product code MYN, Analyzer, Medical Image, regulated at 21 CFR 892.2070 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 29, 2025. The decision came 282 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Bench7, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250264?

K250264 is the FDA 510(k) for SugarBug (1.x), submitted by Bench7, Inc.. FDA's decision date was Nov 7, 2025, under product code MYN (Analyzer, Medical Image).

Who makes the SugarBug (1.x)?

Bench7, Inc., based in Bismarck, ND, is the applicant of record for K250264.

How long did the K250264 review take?

FDA received the submission on Jan 29, 2025 and issued its decision on Nov 7, 2025, 282 days later.

← All decisions in November 2025