FKP — System, Dialysate Delivery, Single Patient Class II
FDA product code FKP covers "System, Dialysate Delivery, Single Patient", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FKP
- Device Class
- Class II
- Regulation Number
- 876.5820
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K181991 | nxstage medical | NxStage Connected Health System | September 26, 2018 |
| K131739 | nxstage medical | NXSTAGE CONNECTED HEALTH SYSTEM | October 10, 2013 |
| K130460 | nxstage medical | NXSTAGE DOSING CALCULATOR | July 11, 2013 |
| K040074 | nxstage medical | ONEVIEW INTERFACE | April 8, 2004 |
| K021060 | fresenius medical care north america | FRESENIUS ICARE MONITORING SYSTEM | November 13, 2002 |
| K003615 | environmental test systems | STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS | February 1, 2001 |
| K992255 | csam | CKHEMO, MODEL CKHEMO VERSION 1.0 | November 30, 1999 |
| K964264 | integrated biomedical technology | HIGH RANGE PEROXIDE TEST STRIP | June 16, 1997 |
| K955423 | fresenius usa | PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM | June 13, 1996 |
| K953854 | integrated biomedical technology | WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE | March 11, 1996 |
| K930181 | fresenius usa | BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE | November 29, 1995 |
| K922757 | baxter healthcare | SPS 1550 SINGLE NEEDLE PATIENT SYSTEM | February 13, 1995 |
| K921456 | fresenius usa | FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM | April 20, 1994 |
| K910215 | cd medical | DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST | April 9, 1991 |
| K905793 | cobe laboratories | COBE CENTRY 2 BICART OPTION KIT | February 12, 1991 |
| K905388 | cobe laboratories | COBE CENTRYSYSTEM 3 BICART OPTION KIT | February 11, 1991 |
| K904967 | gambro-hosp-cobe | HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL | January 28, 1991 |
| K896758 | gambro | GAMBRO BICARBONATE MONITOR BCM 10-3 | September 28, 1990 |
| K896757 | gambro | GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS | August 30, 1990 |
| K894838 | baxter healthcare | HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB | September 7, 1989 |