FDA 510(k)

SOLOPASS 2.0 System

K-Number: K251317 · 2025-09-05

Decision Date2025-09-05

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

SOLOPASS 2.0 System is the device name listed in this FDA 510(k) record. The listed applicant is Intravent Medical Partners. It received FDA 510(k) clearance on 2025-09-05 under 510(k) number K251317. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLOPASS 2.0 System?

SOLOPASS 2.0 System is a medical device that received FDA 510(k) clearance on 2025-09-05. The listed applicant is Intravent Medical Partners. The 510(k) number is K251317.

When did SOLOPASS 2.0 System receive FDA 510(k) clearance?

SOLOPASS 2.0 System received FDA 510(k) clearance on 2025-09-05, under 510(k) number K251317.

Who is the listed applicant for SOLOPASS 2.0 System?

The FDA 510(k) record lists Intravent Medical Partners as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOLOPASS 2.0 System?

The FDA product code for SOLOPASS 2.0 System is HAW.

Related Devices (Code: HAW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.