WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / May 2026 / K260032

510(k) cleared

Morph

BeauBrain Healthcare, Inc. · May 13, 2026 · K260032

FDA cleared the Morph from BeauBrain Healthcare, Inc. on May 13, 2026 under K260032, 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 Jan 6, 2026. The decision came 127 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 BeauBrain Healthcare, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260032?

K260032 is the FDA 510(k) for Morph, submitted by BeauBrain Healthcare, Inc.. FDA's decision date was May 13, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the Morph?

BeauBrain Healthcare, Inc., based in Seoul, is the applicant of record for K260032.

How long did the K260032 review take?

FDA received the submission on Jan 6, 2026 and issued its decision on May 13, 2026, 127 days later.

← All decisions in May 2026