KPF — System, Dialysate Delivery, Semi-Automatic, Peritoneal Class II
FDA product code KPF covers "System, Dialysate Delivery, Semi-Automatic, Peritoneal", a Class II medical device regulated under 21 CFR 876.5630. Submissions are reviewed by the Gastroenterology, Urology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPF
- Device Class
- Class II
- Regulation Number
- 876.5630
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K061515 | baxter healthcare | RENALSOFT | September 11, 2006 |
| K990953 | baxter healthcare | RENAL LINK | June 18, 1999 |
| K970989 | cybernius medical | CYBERREN | July 24, 1997 |
| K955762 | fresenius usa | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | July 31, 1996 |
| K913515 | denco | TOTAL CONTAINMENT DEVICE | May 26, 1994 |
| K875121 | amicon | AMICON EQUALINE FLUID BALANCE SYSTEM | February 19, 1988 |
| K874020 | abbott laboratories | ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE | January 29, 1988 |
| K821328 | medionics international | C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP | July 28, 1982 |
| K802831 | gambro | GAMBRO PERITONEAL DIALYSIS MONITOR | December 18, 1980 |
| K800496 | american medical products | CYCLER W/5 OR 10 HR. FILL/DWELL TIMER | July 21, 1980 |
| K791676 | j.m. sounds electronics | PERITONEAL DIALYSIS CYCLER MODEL PDC1000 | December 6, 1979 |
| K791584 | american medical products | CYLER/HEATER FOR PERITONEAL DIALYSIS | November 16, 1979 |
| K790091 | american medical products | AMP AUTOMATIC CYCLER STAND | February 16, 1979 |