Cleared Traditional

K934914 - ICS 9400 ULTRAVIOLET AIR PURIFIER

K934914 is an FDA 510(k) clearance for ICS 9400 ULTRAVIOLET AIR PURIFIER, manufactured by Medair, Inc.. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K934914 · Medair, Inc. · General Hospital
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Apr 1994
Decision
182d
Days
Class 2
Risk

K934914 is an FDA 510(k) clearance for the ICS 9400 ULTRAVIOLET AIR PURIFIER. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Medair, Inc. (Austin, US). The FDA issued a Cleared decision on April 13, 1994 after a review of 182 days - an extended review cycle.

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 Medair, Inc. devices

FDA 510(k) Submission Details - K934914

510(k) Number K934914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1993
Decision Date April 13, 1994
Days to Decision 182 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 129d · This submission: 182d
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 26
Devices cleared under the same product code (FRA) and FDA review panel - the closest regulatory comparables to K934914.
MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
K972064 · Biological Controls, Inc. · Dec 1997
VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
K954448 · Schiff & Co. · Oct 1996
VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
K960833 · Uv Technologies, Inc. · Jul 1996