DeviceClearance

Product code SCS— General Hospital

Chronos®

Classification name
Ultraviolet Radiation Disinfection Chamber Device
Device class
Class 2
Regulation
21 CFR 880.6511
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code SCS under 21 CFR 880.6511, via openFDA

Market context for product code SCS

FDA has cleared 2 devices under product code SCS between 2024 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SCS

Recent clearances under product code SCS

Data sourced from openFDA. This site is unofficial and independent of the FDA.