510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854259Substantially Equivalent

Sepacell R-500 & Sepacell R-500A

Advocacy International, Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854259 is the FDA 510(k) clearance record for SEPACELL R-500 & SEPACELL R-500A, a class II device, cleared for Advocacy International, Ltd. on under FDA product code CAK (Microfilter, Blood Transfusion). FDA records list 13 510(k) clearances for Advocacy International, Ltd., from to . As of , FDA records show no recalls naming K854259.

Clearance record

Decision date
Received
(77 days to decision)
Product code
CAK Microfilter, Blood Transfusion
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Advocacy International, Ltd. Internationa Sq., Washington DC
Third party review
No

Clearances, product code CAK

Trailing 12 months

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

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