510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800549Substantially Equivalent

Model Triex-L Hollow Fiber Dialyzer

Extracorporeal Medical Specialities, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800549 is the FDA 510(k) clearance record for MODEL TRIEX-L HOLLOW FIBER DIALYZER, a class II device, cleared for Extracorporeal Medical Specialities, Inc. on under FDA product code FJI (Dialyzer, Capillary, Hollow Fiber). FDA records list 69 510(k) clearances for Extracorporeal Medical Specialities, Inc., from to . As of , FDA records show no recalls naming K800549.

Clearance record

Decision date
Received
(31 days to decision)
Product code
FJI Dialyzer, Capillary, Hollow Fiber
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Extracorporeal Medical Specialities, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FJI

Trailing 12 months

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

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