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

System, Dialysate Delivery, Sorbent Regenerated

21 CFR 876.5600 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FKT is the FDA product code for System, Dialysate Delivery, Sorbent Regenerated, a class II device type, regulated under 21 CFR 876.5600. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FKT
Device name
System, Dialysate Delivery, Sorbent Regenerated
Regulation
21 CFR 876.5600
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
19
Ingested recalls
0

Clearances, product code FKT

By decision year
19 clearances under product code FKT with a decision year between 1980 and 2013, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FKT by decision year
YearClearances
19803
19812
19821
19841
19851
19861
19871
19882
19961
20031
20051
20061
20071
20101
20131

Applicants with the most clearances

Product code FKT
Applicants holding the most 510(k) clearances under product code FKT
ApplicantClearances
bioMerieux, Inc.9
Renal Solutions, Inc.6
Ash Medical Systems, Inc.3
Gambro Healthcare1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code FKT.