FEDERAL

Half of 510(k) clearances now go to applicants outside the US

51.1%

of 2026 510(k) clearances to date went to applicants with a non US address

Applicants outside the US received 40.2% of FDA 510(k) clearances in 2018, 41.9% in 2019 and 43.2% in 2020, then 53.3% in 2021. The share has stayed above half since: 53.1% in 2022, 50.4% in 2023, 51.2% in 2024, 52.2% in 2025 and 51.1% so far in 2026.

Volume held steady through the shift, 2,918 to 3,346 clearances a year from 2018 through 2025. 2026 shows 2,345 in the current snapshot with the year not done.

Half the new devices reaching a US purchasing committee now come from a company with no US address on the filing.

ProxiSuite analysis of FDA 510(k) premarket notification database.The Proximity Report

Cite this: Half of 510(k) clearances now go to applicants outside the US, ProxiSuite (2026), based on FDA 510(k) premarket notification database. https://proxisuite.com/report/foreign-510k-share.html

ProxiSuite is not endorsed by or affiliated with any government agency. Analysis based on public federal data.

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