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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 / December 2025 / K252103

510(k) cleared

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

Mighty Oak Medical · Dec 2, 2025 · K252103

FDA cleared the Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) from Mighty Oak Medical on Dec 2, 2025 under K252103, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 3, 2025. The decision came 152 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mighty Oak Medical has 3 other decisions in the tracker over the last 12 months: K260322 (Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)), K253472 (FIREFLY® Pedicle Screw Navigation Guide), K251532 (Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)).

Questions & Answers

What did FDA clear under K252103?

K252103 is the FDA 510(k) for Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX), submitted by Mighty Oak Medical. FDA's decision date was Dec 2, 2025, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)?

Mighty Oak Medical, based in Englewood, CO, is the applicant of record for K252103.

How long did the K252103 review take?

FDA received the submission on Jul 3, 2025 and issued its decision on Dec 2, 2025, 152 days later.

← All decisions in December 2025

Sources