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

Filter, Blood, Dialysis

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FKJ is the FDA product code for Filter, Blood, Dialysis, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FKJ
Device name
Filter, Blood, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code FKJ

By decision year
5 clearances under product code FKJ with a decision year between 1977 and 2026, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FKJ by decision year
YearClearances
19771
19821
19841
19901
20261

Applicants with the most clearances

Product code FKJ
Applicants holding the most 510(k) clearances under product code FKJ
ApplicantClearances
Serim Research Corp.2
BD Becton Dickinson Vacutainer Systems Preanalytic1
Computer Dialysis Systems, Inc.1
Terumo America, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code