510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K161468Substantially Equivalent

Transformair Indoor Air Purifier

Transformair, LLC, Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161468 is the FDA 510(k) clearance record for Transformair Indoor Air Purifier, a class II device, cleared for Transformair, LLC on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list one 510(k) clearance for Transformair, LLC. As of , FDA records show no recalls naming K161468.

Clearance record

Decision date
Received
(257 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Transformair, LLC 3802 Spectrum Blvd. Suite 143, Tampa FL
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code FRA

Trailing 12 months

FDA records hold no clearances under product code FRA in the trailing twelve months.

FDA records show no clearances under product code FRA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FRA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260