Cleared Traditional

K112728 - HEPAIRX VENTILATING AIR PURIFIER

K112728 is an FDA 510(k) clearance for HEPAIRX VENTILATING AIR PURIFIER, manufactured by Air Innovations, Inc.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 491-day FDA review.

K112728 · Air Innovations, Inc. · General Hospital
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Jan 2013
Decision
491d
Days
Class 2
Risk

K112728 is an FDA 510(k) clearance for the HEPAIRX VENTILATING AIR PURIFIER. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Air Innovations, Inc. (North Syracuse, US). The FDA issued a Cleared decision on January 23, 2013 after a review of 491 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Air Innovations, Inc. devices

FDA 510(k) Submission Details - K112728

510(k) Number K112728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2011
Decision Date January 23, 2013
Days to Decision 491 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
362d slower than avg
Panel avg: 129d · This submission: 491d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRF Device Classification - Class 2, Special Controls

Product Code FRF Cleaner, Air, Medical Recirculating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5045
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.