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

Shunt, Peritoneal

21 CFR 876.5955 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KPM is the FDA product code for Shunt, Peritoneal, a class II device type, regulated under 21 CFR 876.5955. As of , FDA records hold 19 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KPM
Device name
Shunt, Peritoneal
Regulation
21 CFR 876.5955
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
19
Ingested recalls
0

Clearances, product code KPM

By decision year
19 clearances under product code KPM with a decision year between 1977 and 2023, 2001 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KPM by decision year
YearClearances
19771
19812
19821
19841
19882
19892
19901
19941
19971
19981
20014
20171
20231

Applicants with the most clearances

Product code KPM
Applicants holding the most 510(k) clearances under product code KPM
ApplicantClearances
Denver Biomedicals, Inc.6
Cerenovus, Inc.3
BD Becton Dickinson Vacutainer Systems Preanalytic2
Denver Biomaterials, Inc.2
Denver Biomedical, Inc.2
Care Fusion1
Cordis US Corp.1
Pleural Dynamics, Inc.1
Vitaid, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code