510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K212824Substantially Equivalent

Bluezone Model RX-450 Air Purifier

Bluezone Products, Inc., Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212824 is the FDA 510(k) clearance record for Bluezone Model RX-450 Air Purifier, a class II device, cleared for Bluezone Products, Inc. on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list one 510(k) clearance for Bluezone Products, Inc. As of , FDA records show no recalls naming K212824.

Clearance record

Decision date
Received
(167 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Bluezone Products, Inc. 225 Wildwood Ave., Woburn MA
510(k) summary
Summary PDF
Third party review
No

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