Cleared Traditional

ABRACAIR AIR CLEANER, MODEL QTZ300-60 (K052732) - FDA 510(k) Clearance

Also marketed or referenced as:
ABRACAIR AIR CLEANER, MODEL TI 100-30P

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K052732 · Abracair, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2006
Decision
148d
Days
Class 2
Risk

K052732 is an FDA 510(k) clearance for the ABRACAIR AIR CLEANER, MODEL QTZ300-60. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Abracair, Inc. (Lousville, US). The FDA issued a Cleared decision on February 24, 2006 after a review of 148 days - within the typical 510(k) review window.

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 Abracair, Inc. devices

Submission Details

510(k) Number K052732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date February 24, 2006
Days to Decision 148 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 129d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 35
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