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

Tank, Holding, Dialysis

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

FIN is the FDA product code for Tank, Holding, Dialysis, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
FIN
Device name
Tank, Holding, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
18
Ingested recalls
4

Clearances, product code FIN

By decision year
18 clearances under product code FIN with a decision year between 1987 and 2015, 2004 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code FIN by decision year
YearClearances
19871
19881
19961
19971
19991
20002
20011
20031
20043
20062
20101
20121
20141
20151

Applicants with the most clearances

Product code FIN
Applicants holding the most 510(k) clearances under product code FIN
ApplicantClearances
AmeriWater LLC.2
Pure Water, Inc.2
Tango3, LLC2
Better Water, Inc.1
Dial Medical Supply1
Dialysis Services, Inc.1
Dialysis Systems, Inc.1
G.E.M. Water Systems1
Isopure Corp1
Mar Cor Services, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code