Cleared Traditional

K960833 - VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM

K960833 is an FDA 510(k) clearance for VIOTEC S-4000-CR SECURITY SERIES ULTRAV..., manufactured by Uv Technologies, Inc.. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K960833 · Uv Technologies, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
147d
Days
Class 2
Risk

K960833 is an FDA 510(k) clearance for the VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Uv Technologies, Inc. (West Cadwell, US). The FDA issued a Cleared decision on July 25, 1996 after a review of 147 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6500 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Uv Technologies, Inc. devices

FDA 510(k) Submission Details - K960833

510(k) Number K960833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1996
Decision Date July 25, 1996
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 129d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRA Device Classification - Class 2, Special Controls

Product Code FRA Purifier, Air, Ultraviolet, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.