510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984116Substantially Equivalent

Hepa-Care Air Cleaner American Air Filter Air Filtration System Models Hc800f, Hfs800f, Hc800c/ Hfs800c, Hc400c/hfs400c

Abatement Technologies Limited, Duluth GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984116 is the FDA 510(k) clearance record for HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C, a class II device, cleared for Abatement Technologies, Inc. on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list one 510(k) clearance for Abatement Technologies, Inc. As of , FDA records show no recalls naming K984116.

Clearance record

Decision date
Received
(219 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Abatement Technologies, Inc. 2220 Northmont Pkwy., #100, Duluth GA
510(k) summary
Statement
Third party review
No

Clearances, product code FRF

Trailing 12 months
1 clearance under product code FRF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260