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

Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

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

KPO is the FDA product code for Dialysate Concentrate For Hemodialysis (Liquid Or Powder), a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 124 510(k) clearances under this code, the most recent dated , and 109 recalls.

Classification record

Product code
KPO
Device name
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
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
124
Ingested recalls
113

Clearances, product code KPO

By decision year
124 clearances under product code KPO with a decision year between 1978 and 2026, 2002 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code KPO by decision year
YearClearances
19782
19803
19815
19824
19832
19841
19853
19863
19875
19882
19895
19904
19916
19945
19961
19972
19985
19994
20002
20012
20029
20034
20044
20054
20061
20072
20082
20091
20111
20122
20131
20142
20151
20161
20173
20182
20205
20211
20222
20233
20243
20252
20262

Applicants with the most clearances

Product code KPO
Applicants holding the most 510(k) clearances under product code KPO
ApplicantClearances
Fresenius Medical Care Renal Therapies Group, LLC13
Baxter Healthcare Corporation7
Gambro Renal Products6
NxStage Medical Inc6
Rockwell Medical6
Di-Chem, Inc.5
Diasol, Inc4
Fresenius USA, Inc.4
Advanced Renal Technologies, Inc.3
B.Braun Medical, Inc.3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order