FDA Product Code SCS: Ultraviolet Radiation Disinfection Chamber Device
An Ultraviolet Radiation Disinfection Chamber Device Is Intended To Disinfect Patient Contacting Medical Devices Using Uv Radiation After The Device Has Been Cleaned. Disinfection Of The Medical Device Is Achieved Within An Enclosed Chamber Through The Exposure To Uv Radiation.
Leading manufacturers include Germitec and UV Smart Technologies B.V..
2
Total
1
Cleared
305d
Avg days
2024
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
274d
recently vs 335d historically
FDA 510(k) Cleared Ultraviolet Radiation Disinfection Chamber Device Devices (Product Code SCS)
2 devices
Cleared
Jan 29, 2026
UV Smart D60
UV Smart Technologies B.V.
General Hospital
274d
Not Cleared
Aug 28, 2024
Chronos®
Germitec
General Hospital
335d
About Product Code SCS - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SCS since 2024, with 1 receiving FDA clearance (average review time: 305 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - SCS Product Code
Recent submissions under SCS have taken an average of 274 days to reach a decision - down from 335 days historically, suggesting improved FDA processing for this classification.
SCS devices are reviewed by the General Hospital panel. Browse all General Hospital devices →