Cleared Traditional

K161468 - Transformair Indoor Air Purifier

K161468 is an FDA 510(k) clearance for Transformair Indoor Air Purifier, manufactured by Transformair, LLC. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K161468 · Transformair, LLC · General Hospital
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Feb 2017
Decision
257d
Days
Class 2
Risk

K161468 is an FDA 510(k) clearance for the Transformair Indoor Air Purifier. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Transformair, LLC (Tampa, US). The FDA issued a Cleared decision on February 8, 2017 after a review of 257 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 Transformair, LLC devices

FDA 510(k) Submission Details - K161468

510(k) Number K161468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2016
Decision Date February 08, 2017
Days to Decision 257 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 129d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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.