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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 / January 2026 / K252674

510(k) cleared

Solo Pace Fusion System (SOLOFUSE1)

Solo Pace, Inc. · Jan 9, 2026 · K252674

FDA cleared the Solo Pace Fusion System (SOLOFUSE1) from Solo Pace, Inc. on Jan 9, 2026 under K252674, a traditional 510(k). The device falls under product code DQX, Wire, Guide, Catheter, regulated at 21 CFR 870.1330 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Aug 25, 2025. The decision came 137 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 Solo Pace, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252674?

K252674 is the FDA 510(k) for Solo Pace Fusion System (SOLOFUSE1), submitted by Solo Pace, Inc.. FDA's decision date was Jan 9, 2026, under product code DQX (Wire, Guide, Catheter).

Who makes the Solo Pace Fusion System (SOLOFUSE1)?

Solo Pace, Inc., based in San Francisco, CA, is the applicant of record for K252674.

How long did the K252674 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Jan 9, 2026, 137 days later.

← All decisions in January 2026