Cleared Traditional

Intellidrop

K251598 · Brainspace, Inc. · Neurology
Dec 2025
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K251598 is an FDA 510(k) clearance for the Intellidrop, a Shunt, Central Nervous System And Components (Class II — Special Controls, product code JXG), submitted by Brainspace, Inc. (Bothell, US). The FDA issued a Cleared decision on December 10, 2025, 197 days after receiving the submission on May 27, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5550.

Submission Details

510(k) Number K251598 FDA.gov
FDA Decision Cleared SESE
Date Received May 27, 2025
Decision Date December 10, 2025
Days to Decision 197 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code JXG — Shunt, Central Nervous System And Components
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5550

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