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 / December 2025 / K251598

510(k) cleared

Intellidrop

Brainspace, Inc. · Dec 10, 2025 · K251598

FDA cleared the Intellidrop from Brainspace, Inc. on Dec 10, 2025 under K251598, a traditional 510(k). The device falls under product code JXG, Shunt, Central Nervous System And Components, regulated at 21 CFR 882.5550 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on May 27, 2025. The decision came 197 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 Brainspace, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251598?

K251598 is the FDA 510(k) for Intellidrop, submitted by Brainspace, Inc.. FDA's decision date was Dec 10, 2025, under product code JXG (Shunt, Central Nervous System And Components).

Who makes the Intellidrop?

Brainspace, Inc., based in Bothell, WA, is the applicant of record for K251598.

How long did the K251598 review take?

FDA received the submission on May 27, 2025 and issued its decision on Dec 10, 2025, 197 days later.

← All decisions in December 2025