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

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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

FJK is the FDA product code for Set, Tubing, Blood, With And Without Anti-Regurgitation Valve, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 77 510(k) clearances under this code, the most recent dated , and 35 recalls.

Classification record

Product code
FJK
Device name
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
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
77
Ingested recalls
36

Clearances, product code FJK

By decision year
77 clearances under product code FJK with a decision year between 1977 and 2026, 1985 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code FJK by decision year
YearClearances
19772
19781
19792
19803
19814
19822
19833
19856
19861
19873
19882
19891
19904
19912
19921
19931
19952
19963
19972
19981
19991
20005
20011
20022
20041
20074
20081
20091
20101
20122
20141
20161
20171
20181
20213
20231
20241
20251
20262

Applicants with the most clearances

Product code FJK
Applicants holding the most 510(k) clearances under product code FJK
ApplicantClearances
National Medical Care, Medical Products Div., Inc.7
Extracorporeal Medical Specialities, Inc.6
Fresenius Medical Care Renal Therapies Group, LLC5
Bain Medical Equipment(guangzhou) Co., Ltd.3
Gambro Renal Products3
Bioteque Corp.2
Erika, Inc.2
Erika, Inc.2
Gambro, Inc.2
Medisystems Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 53 companies shown, in name order