Cleared Traditional

SOLOPASS 2.0 System

K251317 · Intravent Medical Partners · Neurology

Sep 2025

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K251317 is an FDA 510(k) clearance for the SOLOPASS 2.0 System, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Intravent Medical Partners (Blue Bell, US). The FDA issued a Cleared decision on September 5, 2025, 129 days after receiving the submission on April 29, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K251317 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2025
Decision Date	September 05, 2025
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF