SOLOPASS 2.0 System— 510(k) K251317

Name: FDA 510(k) clearance K251317
Creator: U.S. Food and Drug Administration
Published: 2025-09-05

Substantially Equivalent

Intravent Medical Partners

FDA 510(k) clearance K251317 for SOLOPASS 2.0 System, Substantially Equivalent on 2025-09-05. Applicant: Intravent Medical Partners. Device class: 2.

Clearance details

Applicant: Intravent Medical Partners
Product code: Code HAW
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-04-29
Decision date: 2025-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Blue Bell, PA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HAW

product code HAW

Death: 52
Injury: 1,083
Malfunction: 17,300
Total: 18,435

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.