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

Protector, Transducer, Dialysis

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

FIB is the FDA product code for Protector, Transducer, Dialysis, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 35 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FIB
Device name
Protector, Transducer, Dialysis
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
35
Ingested recalls
0

Clearances, product code FIB

By decision year
35 clearances under product code FIB with a decision year between 1981 and 2024, 1981 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code FIB by decision year
YearClearances
19814
19821
19853
19862
19871
19893
19904
19914
19921
19942
19972
19981
20003
20012
20081
20241

Applicants with the most clearances

Product code FIB
Applicants holding the most 510(k) clearances under product code FIB
ApplicantClearances
Filtertek, Inc.5
Medisystems Corp.3
Nipro Medical Corporation3
Fresenius Medical Care Renal Therapies Group, LLC2
Mediflex Intl.2
Akcess Medical Products, Inc.1
Arbo Medical, Inc.1
Bain Medical Equipment(guangzhou) Co., Ltd.1
Bipore, Inc.1
Circulatory Technology, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order