Medical Device Manufacturer · US , Petaluma , CA

Solo Pace, Inc. - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2025

2

Total

2

Cleared

0

Denied

FDA 510(k) cleared devices by Solo Pace, Inc. Cardiovascular ✕

2 devices

1-2 of 2

Cleared Jan 09, 2026

Solo Pace Fusion System (SOLOFUSE1)

Cardiovascular · 137d

Cleared Jan 10, 2025

Solo Pace Control

Cardiovascular · 204d

Data Source

Sourced from the FDA 510(k) public files . 5,377 total devices indexed.

Last updated: Apr 09, 2026