Subsystem, Proportioning
FDA product code FKR · Class II (moderate risk) · 21 CFR 876.5820 · Gastroenterology, Urology
12510(k) clearances
0PMA approvals
10recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140571 | Nxstage Pureflow SLFKR · Special | Nxstage Medical, Inc. | 05/15/2014SE |
| K111174 | Nxstage Pureflow SLFKR · Special | Nxstage Medical, Inc. | 09/19/2011SE |
| K080919 | Nxstage Pureflow SLFKR · Traditional | Nxstage Medical, Inc. | 10/15/2008SE |
| K060296 | Nxstage Dialysate Preparation ModuleFKR · Special | Nxstage Medical, Inc. | 03/31/2006SE |
| K043436 | Nxstage Dialysate Preparation Module, Model NX0269FKR · Traditional | Nxstage Medical, Inc. | 03/17/2005SE |
| K850435 | Sartorius Aquasart SM 40035 - Dialysate SysFKR · Traditional | Sartorius Filters, Inc. | 06/04/1985SE |
| K850756 | Auto-D Automatic Disinfection Access/AttachmentsFKR · Traditional | Travenol Laboratories, S.A. | 03/20/1985SE |
| K810605 | Chematic Bicarbonate Dialysate SystemFKR · Traditional | Trimedyne, Inc. | 06/16/1981SE |
| K810127 | Gambro Bicarbonate Module, BCM-10FKR · Traditional | Gambro, Inc. | 02/25/1981SE |
| K802465 | Bicarb-O-Mate Hemodialysis Sod. Bicarb.FKR · Traditional | Renal Systems, Inc. | 11/12/1980SE |
| K800772 | Mod. DM-357 Bicarbonate Retrofit KitFKR · Traditional | Extracorporeal Medical Specialities, Inc. | 05/14/1980SE |
| K781303 | Bio-Pro UnitFKR · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/02/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0811-2018 Class II | NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020…May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis… | NxStage Medical, Inc. | 01/29/2018Terminated |
| Z-1861-2014 Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407…SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | NxStage Medical, Inc. | 05/14/2014Terminated |
| Z-1860-2014 Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307…SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | NxStage Medical, Inc. | 05/14/2014Terminated |
| Z-1859-2014 Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306…SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | NxStage Medical, Inc. | 05/14/2014Terminated |
| Z-1858-2014 Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305…SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | NxStage Medical, Inc. | 05/14/2014Terminated |
| Z-1857-2014 Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304…SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | NxStage Medical, Inc. | 05/14/2014Terminated |
| Z-1856-2014 Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303…SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | NxStage Medical, Inc. | 05/14/2014Terminated |
| Z-1855-2014 Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302…SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | NxStage Medical, Inc. | 05/14/2014Terminated |
| Z-1854-2014 Class II | NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301…SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | NxStage Medical, Inc. | 05/14/2014Terminated |
| Z-0826-2012 | NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with…Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the… | NxStage Medical, Inc. | 12/14/2011Terminated |