510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201220Substantially Equivalent

Aerus Medical Guardian,model F170A

Aerus Medical, LLC, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K201220 is the FDA 510(k) clearance record for Aerus Medical Guardian,model F170A, a class II device, cleared for Aerus Medical, LLC on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list one 510(k) clearance for Aerus Medical, LLC. As of , FDA records show no recalls naming K201220.

Clearance record

Decision date
Received
(42 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Aerus Medical, LLC 14841 Dallas Pkwy.,, Dallas TX
510(k) summary
Statement
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