Solo Pace, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Solo Pace, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Solo Pace Fusion System (SOLOFUSE1), Solo Pace Control
2
Total
2
Cleared
0
Denied
Solo Pace, Inc. has 2 FDA 510(k) cleared medical devices. Based in Petaluma, US.
Latest FDA clearance: Jan 2026. Active since 2025. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Solo Pace, Inc. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Insight Medical Consulting, LLC and Gateway Medical Consulting Services, LLC.
FDA 510(k) Regulatory Record - Solo Pace, Inc.
2 devices