Medical Device Manufacturer · US , Wheat Ridge , CO

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

2 submissions · 2 cleared · Since 2005

Recent clearances: MCKINLEY SATURATION CATHETER, MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mckinley Medical, LLC General Hospital ✕

2 devices

1-2 of 2

Cleared Apr 12, 2006

MCKINLEY SATURATION CATHETER

General Hospital · 85d

Cleared Apr 14, 2005

MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT

General Hospital · 20d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 26, 2026