FKR
12 FDA 510(k) clearances · Product code
70 daysmedian time to decision
145 days90th percentile
12clearances measured
FDA profile
- Official device name
- Subsystem, Proportioning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| NXSTAGE PUREFLOW SL (K140571) | Nxstage Medical, Inc. | 2014-05-15 |
| NXSTAGE PUREFLOW SL (K111174) | Nxstage Medical, Inc. | 2011-09-19 |
| NXSTAGE PUREFLOW SL (K080919) | Nxstage Medical, Inc. | 2008-10-15 |
| NXSTAGE DIALYSATE PREPARATION MODULE (K060296) | Nxstage Medical, Inc. | 2006-03-31 |
| NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 (K043436) | Nxstage Medical, Inc. | 2005-03-17 |
| SARTORIUS AQUASART SM 40035 - DIALYSATE SYS (K850435) | Sartorius Filters, Inc. | 1985-06-04 |
| AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS (K850756) | Travenol Laboratories, S.A. | 1985-03-20 |
| CHEMATIC BICARBONATE DIALYSATE SYSTEM (K810605) | Trimedyne, Inc. | 1981-06-16 |
| GAMBRO BICARBONATE MODULE, BCM-10 (K810127) | Gambro, Inc. | 1981-02-25 |
| BICARB-O-MATE HEMODIALYSIS SOD. BICARB. (K802465) | Renal Systems, Inc. | 1980-11-12 |
| MOD. DM-357 BICARBONATE RETROFIT KIT (K800772) | Extracorporeal Medical Specialities, Inc. | 1980-05-14 |
| BIO-PRO UNIT (K781303) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-02 |
Track FKR automatically
Every clearance here is in the API, with alerts when new ones post.