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

System, Dialysate Delivery, Semi-Automatic, Peritoneal

21 CFR 876.5630 / Gastroenterology, Urology
FDA source (opens on fda.gov)

KPF is the FDA product code for System, Dialysate Delivery, Semi-Automatic, Peritoneal, a class II device type, regulated under 21 CFR 876.5630. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
KPF
Device name
System, Dialysate Delivery, Semi-Automatic, Peritoneal
Regulation
21 CFR 876.5630
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
13
Ingested recalls
5

Clearances, product code KPF

By decision year
13 clearances under product code KPF with a decision year between 1979 and 2006, 1979 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KPF by decision year
YearClearances
19793
19802
19821
19882
19941
19961
19971
19991
20061

Applicants with the most clearances

Product code KPF
Applicants holding the most 510(k) clearances under product code KPF
ApplicantClearances
American Medical Products LLC3
Baxter Healthcare Corporation2
Abbott Medical1
Amicon, Inc.1
Cybernius Medical, Ltd.1
Denco1
Fresenius USA, Inc.1
Gambro, Inc.1
J.M. Sounds Electronics Co.1
Medionics International, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code