510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864636Substantially Equivalent

Erypur B

bioMerieux, Inc., Kensington TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864636 is the FDA 510(k) clearance record for ERYPUR B, a class II device, cleared for Organon Teknika Corp. on under FDA product code CAK (Microfilter, Blood Transfusion). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K864636.

Clearance record

Decision date
Received
(49 days to decision)
Product code
CAK Microfilter, Blood Transfusion
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Organon Teknika Corp. 5516 Nicholson Ln., Kensington TX
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