510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052732Substantially Equivalent

Abracair Air Cleaner, Model Qtz300-60; Abracair Air Cleaner, Model Ti 100-30P

Abracair, Inc., Lousville KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052732 is the FDA 510(k) clearance record for ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P, a class II device, cleared for Abracair, Inc. on under FDA product code FRA (Purifier, Air, Ultraviolet, Medical). FDA records list one 510(k) clearance for Abracair, Inc. As of , FDA records show no recalls naming K052732.

Clearance record

Decision date
Received
(148 days to decision)
Product code
FRA Purifier, Air, Ultraviolet, Medical
Regulation
21 CFR 880.6500
Device class
Class II
Review panel
General Hospital
Applicant
Abracair, Inc. 801 Barret Ave., Lousville KY
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