FKR — Subsystem, Proportioning Class II
FDA Device Classification
Classification Details
- Product Code
- FKR
- 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 |
| K140571 | nxstage medical | NXSTAGE PUREFLOW SL | May 15, 2014 |
| K111174 | nxstage medical | NXSTAGE PUREFLOW SL | September 19, 2011 |
| K080919 | nxstage medical | NXSTAGE PUREFLOW SL | October 15, 2008 |
| K060296 | nxstage medical | NXSTAGE DIALYSATE PREPARATION MODULE | March 31, 2006 |
| K043436 | nxstage medical | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 | March 17, 2005 |
| K850435 | sartorius filters | SARTORIUS AQUASART SM 40035 - DIALYSATE SYS | June 4, 1985 |
| K850756 | travenol laboratories | AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS | March 20, 1985 |
| K810605 | trimedyne | CHEMATIC BICARBONATE DIALYSATE SYSTEM | June 16, 1981 |
| K810127 | gambro | GAMBRO BICARBONATE MODULE, BCM-10 | February 25, 1981 |
| K802465 | renal systems | BICARB-O-MATE HEMODIALYSIS SOD. BICARB. | November 12, 1980 |
| K800772 | extracorporeal medical specialities | MOD. DM-357 BICARBONATE RETROFIT KIT | May 14, 1980 |
| K781303 | bd becton dickinson vacutainer systems preanalytic | BIO-PRO UNIT | October 2, 1978 |