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

Accessories, Blood Circuit, Hemodialysis

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

KOC is the FDA product code for Accessories, Blood Circuit, Hemodialysis, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 182 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
KOC
Device name
Accessories, Blood Circuit, Hemodialysis
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
182
Ingested recalls
17

Clearances, product code KOC

By decision year
182 clearances under product code KOC with a decision year between 1976 and 2025, 1983 the highest year at 39.
Show the numbers
510(k) clearances under FDA product code KOC by decision year
YearClearances
197621
197715
19781
19794
19804
19816
198212
198339
198419
19854
19861
19892
19903
19916
19923
19932
19944
19955
19962
19974
19991
20003
20012
20022
20031
20071
20082
20092
20121
20141
20152
20161
20171
20201
20232
20252

Applicants with the most clearances

Product code KOC
Applicants holding the most 510(k) clearances under product code KOC
ApplicantClearances
Sorensen Research22
Extracorporeal Medical Specialities, Inc.11
Gambro, Inc.9
Erika, Inc.8
Travenol Laboratories, S.A.8
Fresenius Medical Care Renal Therapies Group, LLC7
Erika, Inc.5
Medisystems Corp.5
Nikkiso Co., Ltd.5
bioMerieux, Inc.5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 40 companies shown, in name order