510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852764Substantially Equivalent

Idecap Dialyzer

Trans-National Trade Development Corp., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852764 is the FDA 510(k) clearance record for IDECAP DIALYZER, a class II device, cleared for Trans-National Trade Development Corp. on under FDA product code FJH (Dialyzer, Disposable). FDA records list 2 510(k) clearances for Trans-National Trade Development Corp., from to . As of , FDA records show no recalls naming K852764.

Clearance record

Decision date
Received
(84 days to decision)
Product code
FJH Dialyzer, Disposable
Regulation
21 CFR 876.5830
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Trans-National Trade Development Corp. 2 Dag Hammarskjold Plz., New York NY
Third party review
No

Clearances, product code FJH

Trailing 12 months

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

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