FKR — Subsystem, Proportioning Class II
FDA product code FKR covers "Subsystem, Proportioning", a Class II medical device regulated under 21 CFR 876.5820. Submissions are reviewed by the Gastroenterology, Urology panel. At least 12 recent 510(k) clearances have been granted under this product code.
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 |