Cleared Traditional

K012549 - ADVANCED AIR PURIFICATION SYSTEM

Also marketed or referenced as:
HEPA AIR CLEANING SYSTEM

K012549 is an FDA 510(k) clearance for ADVANCED AIR PURIFICATION SYSTEM, manufactured by Healthway Products, Inc.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K012549 · Healthway Products, Inc. · General Hospital
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Feb 2002
Decision
181d
Days
Class 2
Risk

K012549 is an FDA 510(k) clearance for the ADVANCED AIR PURIFICATION SYSTEM. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Healthway Products, Inc. (Syracuse, US). The FDA issued a Cleared decision on February 4, 2002 after a review of 181 days - an extended review cycle.

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: 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 Healthway Products, Inc. devices

FDA 510(k) Submission Details - K012549

510(k) Number K012549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2001
Decision Date February 04, 2002
Days to Decision 181 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
52d slower than avg
Panel avg: 129d · This submission: 181d
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.