FDA product code SCS: Ultraviolet Radiation Disinfection Chamber Device
SCS is the FDA product code for ultraviolet radiation disinfection chamber device. It is a Class II device, regulated under 21 CFR 880.6511 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under SCS, 1 in the last five years. The average 510(k) review took 274 days (median 274); 274 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Ultraviolet Radiation Disinfection Chamber Device |
| Device class | Class II |
| Regulation | 21 CFR 880.6511 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for SCS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 274 |
Compare with all 510(k) review times · Search every SCS clearance
Top SCS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| UV Smart Technologies B.V. | 1 | 2026-01-29 |
Most recent SCS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251354 | UV Smart Technologies B.V. | UV Smart D60 | 2026-01-29 | 274 |
Recalls for SCS devices
openFDA lists no recalls for product code SCS.
Frequently asked questions
What is FDA product code SCS?
SCS is the FDA product code for ultraviolet radiation disinfection chamber device. It is a Class II device, regulated under 21 CFR 880.6511 and reviewed by the General Hospital panel.
What device class is SCS?
Class II, regulation 21 CFR 880.6511. Typical premarket route: 510(k).
How long does a 510(k) take for product code SCS?
Across 1 cleared submissions the average was 274 days from receipt to decision (median 274).
Which companies have the most SCS clearances?
UV Smart Technologies B.V. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code SCS
- Run a recall and safety report across every SCS manufacturer
- Watch product code SCS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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