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SOLOPASS 2.0 System

by Intravent Medical Partners

510(k) K251317

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251317 Date5 Sep 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HAW
Device Class
Class II
Regulation
21 CFR Part 882.4560
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SOLOPASS 2.0 System is a bedside navigation system designed for intra-procedural localization and navigation using 2D and 3D ultrasound imaging, artificial intelligence, and trajectory guidance. It combines frameless fixation with image guidance to provide accurate localization during brain pressure-relief procedures.

The system is supplied by Intravent Medical Partners and has received FDA 510(k) clearance with the product code HAW. It is intended for use in neurology procedures and is designed to be portable for bedside use. The system utilizes ultrasound imaging technology to assist in real-time navigation during critical neurosurgical interventions.

Other devices from Intravent Medical Partners, LP

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the SOLOPASS 2.0 System used for?

    The SOLOPASS 2.0 System is a bedside navigation system designed for intra-procedural localization and navigation during brain pressure-relief procedures. It combines frameless fixation with image guidance using 2D and 3D ultrasound imaging, artificial intelligence, and trajectory guidance to provide accurate localization.

  • How is the SOLOPASS 2.0 System supplied?

    The SOLOPASS 2.0 System is supplied by Intravent Medical Partners. It is designed to be portable for bedside use in neurology procedures, utilizing ultrasound imaging technology to assist in real-time navigation during critical neurosurgical interventions.

  • What regulatory approvals does the SOLOPASS 2.0 System have?

    The SOLOPASS 2.0 System has received FDA 510(k) clearance with the product code HAW. It was determined to be substantially equivalent to predicate devices and reviewed by the Neurology advisory committee.

  • Is the SOLOPASS 2.0 System reusable or single-use?

    The device data does not specify whether the SOLOPASS 2.0 System is reusable or single-use. The system is designed for bedside use in neurology procedures and combines frameless fixation with image guidance, but specific information regarding reusability is not provided in the available documentation.