System, Dialysate Delivery, Semi-Automatic, Peritoneal
This device is a semi-automatic peritoneal dialysate delivery system used to prepare and deliver dialysis fluid for patients undergoing peritoneal dialysis to manage kidney failure. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPF, regulated under 21 CFR 876.5630 within the Gastroenterology and Urology specialty. This device is designated as life-sustaining or life-supporting, reflecting its critical role in renal replacement therapy.
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Basic Information
- Product Code
- KPF
- Device Class
- FDA class 2
- Regulation Number
- 876.5630
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K061515 | RENALSOFT | Sep 11, 2006 | Substantially Equivalent | Baxter Healthcare Corp |
| K990953 | RENAL LINK | Jun 18, 1999 | Substantially Equivalent | Baxter Healthcare Corp |
| K970989 | CYBERREN | Jul 24, 1997 | Substantially Equivalent | Cybernius Medical , Ltd. |
| K955762 | PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | Jul 31, 1996 | Substantially Equivalent | Fresenius USA, Inc. |
| K913515 | TOTAL CONTAINMENT DEVICE | May 26, 1994 | Substantially Equivalent | Denco |
| K875121 | AMICON EQUALINE FLUID BALANCE SYSTEM | Feb 19, 1988 | Substantially Equivalent | Amicon, Inc. |
| K874020 | ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE | Jan 29, 1988 | Substantially Equivalent | Abbott Laboratories |
| K821328 | C.A.P.D. AUTOMATIC HEATER #PDC 2000 HCP | Jul 28, 1982 | Substantially Equivalent | Medionics International , Ltd. |
| K802831 | GAMBRO PERITONEAL DIALYSIS MONITOR | Dec 18, 1980 | Substantially Equivalent | Gambro, Inc. |
| K800496 | CYCLER W/5 OR 10 HR. FILL/DWELL TIMER | Jul 21, 1980 | Substantially Equivalent | American Medical Products, Inc. |
| K791676 | PERITONEAL DIALYSIS CYCLER MODEL PDC1000 | Dec 06, 1979 | Substantially Equivalent | J.M. Sounds Electronics Co. |
| K791584 | CYLER/HEATER FOR PERITONEAL DIALYSIS | Nov 16, 1979 | Substantially Equivalent | American Medical Products, Inc. |
| K790091 | AMP AUTOMATIC CYCLER STAND | Feb 16, 1979 | Substantially Equivalent | American Medical Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.