WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / September 2025 / K251317

510(k) cleared

SOLOPASS 2.0 System

Intravent Medical Partners · Sep 5, 2025 · K251317

FDA cleared the SOLOPASS 2.0 System from Intravent Medical Partners on Sep 5, 2025 under K251317, a traditional 510(k). The device falls under product code HAW, Neurological Stereotaxic Instrument, regulated at 21 CFR 882.4560 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Apr 29, 2025. The decision came 129 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Intravent Medical Partners in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251317?

K251317 is the FDA 510(k) for SOLOPASS 2.0 System, submitted by Intravent Medical Partners. FDA's decision date was Sep 5, 2025, under product code HAW (Neurological Stereotaxic Instrument).

Who makes the SOLOPASS 2.0 System?

Intravent Medical Partners, based in Blue Bell, PA, is the applicant of record for K251317.

How long did the K251317 review take?

FDA received the submission on Apr 29, 2025 and issued its decision on Sep 5, 2025, 129 days later.

← All decisions in September 2025