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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Consultant

Third Party Review Group, LLC
DAVE YUNGVIRT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRA Purifier, Air, Ultraviolet, Medical

All 32
Devices cleared under the same product code (FRA) and FDA review panel - the closest regulatory comparables to K161468.
AEROCURE-MD
K203189 · Aerobiotix, Inc. · Jan 2021
Aerus Medical Guardian,model F170A
K201220 · Aerus Medical, LLC · Jun 2020
Molekule Air Pro RX
K200500 · Molekule, Inc. · Apr 2020
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI
K133800 · Hgi Industires · Dec 2014
ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400
K062716 · Eco-Rx, Inc. · Oct 2006
ABRACAIR AIR CLEANER, MODEL QTZ300-60
K052732 · Abracair, Inc. · Feb 2006

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.