Expanse Medical, Inc. - FDA 510(k) Cleared Devices

Expanse Medical, Inc. is an engineering-first venture studio that designs and develops regulated medical devices. The company operates with facilities in the San Francisco Bay Area and Providence, Rhode Island, with an FDA registered manufacturing facility in Pleasanton, California. Expanse transforms clinical insights into market-ready devices through first-principles engineering and disciplined execution.

The company has received 3 FDA 510(k) clearances from 3 total submissions, with all submissions focused on Cardiovascular devices. First clearance occurred in 2024, with the most recent clearance in 2026, demonstrating active regulatory engagement. Notable cleared devices include aspiration systems designed for interventional cardiology and vascular procedures.

Expanse Medical's leadership has filed over 180 patents and previously led products acquired or distributed by Boston Scientific, Medtronic, Philips, Teleflex, J&J, and Genesis Medtech. The company operates a Build-to-Buy model for strategic partners, managing device development from design through FDA clearance and commercial transfer. Products developed by the team have generated over $1 billion in global sales.

Explore the company's cleared device names, product codes, and clearance dates in the full 510(k) database record.