510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854084Substantially Equivalent

Pediatric Hemodialysis Replacement Pump Segment

bioMerieux, Inc., Oklahoma City OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854084 is the FDA 510(k) clearance record for PEDIATRIC HEMODIALYSIS REPLACEMENT PUMP SEGMENT, a class II device, cleared for Organon Teknika Corp. on under FDA product code FKL (Insert, Pump, Blood). FDA records list 408 510(k) clearances for BIOMERIEUX, INC., from to . As of , FDA records show no recalls naming K854084.

Clearance record

Decision date
Received
(32 days to decision)
Product code
FKL Insert, Pump, Blood
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Organon Teknika Corp. 5300 S. Portland Ave., Oklahoma City OK
Third party review
No

Clearances, product code FKL

Trailing 12 months

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

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