Cleared Traditional

Solo Pace Fusion System (SOLOFUSE1)

K252674 · Solo Pace, Inc. · Cardiovascular

Jan 2026

Decision

137d

Days

Class 2

Risk

About This 510(k) Submission

K252674 is an FDA 510(k) clearance for the Solo Pace Fusion System (SOLOFUSE1), a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Solo Pace, Inc. (San Francisco, US). The FDA issued a Cleared decision on January 9, 2026, 137 days after receiving the submission on August 25, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.

Submission Details

510(k) Number	K252674 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2025
Decision Date	January 09, 2026
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF