Cleared Traditional

K954448 - VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM

K954448 is an FDA 510(k) clearance for VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AI..., manufactured by Schiff & Co.. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K954448 · Schiff & Co. · General Hospital
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Oct 1996
Decision
399d
Days
Class 2
Risk

K954448 is an FDA 510(k) clearance for the VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Schiff & Co. (West Cadwell, US). The FDA issued a Cleared decision on October 28, 1996 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K954448

510(k) Number K954448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1995
Decision Date October 28, 1996
Days to Decision 399 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
270d slower than avg
Panel avg: 129d · This submission: 399d
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.

Regulatory Peers - FRA Purifier, Air, Ultraviolet, Medical

All 34
Devices cleared under the same product code (FRA) and FDA review panel - the closest regulatory comparables to K954448.
AIROCIDE TI02
K023830 · Kes Science & Technology, Inc. · Feb 2003
SECOND WIND AIR PURIFIER
K980745 · Monagan Ent., Inc. · Apr 1999
MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
K972064 · Biological Controls, Inc. · Dec 1997
VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
K960833 · Uv Technologies, Inc. · Jul 1996
RXAIR 3000
K951981 · Clean Air Research & Development · Oct 1995
VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE
K943521 · Schiff & Co. · Feb 1995
K954448 · VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
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