Medical Device Manufacturer · US , Woodbridge , CT

K1 Medical, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2019

Total

Cleared

Denied

K1 Medical, LLC has 4 FDA 510(k) cleared medical devices. Based in Woodbridge, US.

Last cleared in 2021. Active since 2019. Primary specialty: General Hospital.

Browse the FDA 510(k) cleared devices submitted by K1 Medical, LLC Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Joseph Azary as regulatory consultant.

K1 Medical, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - K1 Medical, LLC

4 devices

1-4 of 4

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 23, 2026