510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843504Substantially Equivalent

Amer. Bentley Hemofilter Holder Hfh-1

American Bentley, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843504 is the FDA 510(k) clearance record for AMER. BENTLEY HEMOFILTER HOLDER HFH-1, a class II device, cleared for American Bentley on under FDA product code FKI (Set, Dialyzer Holder). FDA records list 59 510(k) clearances for American Bentley, from to . As of , FDA records show no recalls naming K843504.

Clearance record

Decision date
Received
(42 days to decision)
Product code
FKI Set, Dialyzer Holder
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
American Bentley 17502 Armstrong Ave., Irvine CA
Third party review
No

Clearances, product code FKI

Trailing 12 months

FDA records hold no clearances under product code FKI in the trailing twelve months.

FDA records show no clearances under product code FKI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FKI, 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