Cleared Traditional

K951981 - RXAIR 3000

K951981 is an FDA 510(k) clearance for RXAIR 3000, manufactured by Clean Air Research & Development. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K951981 · Clean Air Research & Development · General Hospital
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Oct 1995
Decision
168d
Days
Class 2
Risk

K951981 is an FDA 510(k) clearance for the RXAIR 3000. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Clean Air Research & Development (Dallas, US). The FDA issued a Cleared decision on October 12, 1995 after a review of 168 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 Clean Air Research & Development devices

FDA 510(k) Submission Details - K951981

510(k) Number K951981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1995
Decision Date October 12, 1995
Days to Decision 168 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
39d slower than avg
Panel avg: 129d · This submission: 168d
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 K951981.
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