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

Tray, Start/Stop (Including Contents), Dialysis

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

FKG is the FDA product code for Tray, Start/Stop (Including Contents), Dialysis, a class I device type, regulated under 21 CFR 876.5820. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
FKG
Device name
Tray, Start/Stop (Including Contents), Dialysis
Regulation
21 CFR 876.5820
Device class
Class I
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
11

Clearances, product code FKG

By decision year
6 clearances under product code FKG with a decision year between 1979 and 1995, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FKG by decision year
YearClearances
19792
19811
19841
19871
19951

Applicants with the most clearances

Product code FKG
Applicants holding the most 510(k) clearances under product code FKG
ApplicantClearances
Argon Medical Corp.1
Cutter Laboratories, Inc.1
Dove Medical Supplies1
J.J. Skinner, Inc.1
Med-Pak Corp.1
Professional Dialysis Products1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order