510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203189Substantially Equivalent

Aerocure-Md

Aerobiotix, Inc., Miamisburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203189 is the FDA 510(k) clearance record for AEROCURE-MD, a class II device, cleared for Aerobiotix, Inc. on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list one 510(k) clearance for Aerobiotix, Inc. As of , FDA records show no recalls naming K203189.

Clearance record

Decision date
Received
(86 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Aerobiotix, Inc. 444 Alexandersville Rd., Miamisburg OH
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