Product code FKR
- Device name
- Subsystem, Proportioning
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140571 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2014-05-15 |
| K111174 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2011-09-19 |
| K080919 | NXSTAGE PUREFLOW SL | Nxstage Medical, Inc. | 2008-10-15 |
| K060296 | NXSTAGE DIALYSATE PREPARATION MODULE | Nxstage Medical, Inc. | 2006-03-31 |
| K043436 | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 | Nxstage Medical, Inc. | 2005-03-17 |
| K850435 | SARTORIUS AQUASART SM 40035 - DIALYSATE SYS | Sartorius Filters, Inc. | 1985-06-04 |
| K850756 | AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS | Travenol Laboratories, S.A. | 1985-03-20 |
| K810605 | CHEMATIC BICARBONATE DIALYSATE SYSTEM | Trimedyne, Inc. | 1981-06-16 |
| K810127 | GAMBRO BICARBONATE MODULE, BCM-10 | Gambro, Inc. | 1981-02-25 |
| K802465 | BICARB-O-MATE HEMODIALYSIS SOD. BICARB. | Renal Systems, Inc. | 1980-11-12 |
| K800772 | MOD. DM-357 BICARBONATE RETROFIT KIT | Extracorporeal Medical Specialities, Inc. | 1980-05-14 |
| K781303 | BIO-PRO UNIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-10-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| M535NX200011D0 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2023-12-04 |
| M535NX20002A0 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2016-11-17 |
| M535NX20001CAN0 | PUREFLOW SL - CONTROL UNIT | NXSTAGE MEDICAL, INC. | 2016-07-21 |
| M535NX20002CAN0 | PUREFLOW SL - CHASSIS | NXSTAGE MEDICAL, INC. | 2016-07-21 |
| M535SAK307A0 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-10-30 |
| M535SAK306A0 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-10-30 |
| M535SAK305A0 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-10-30 |
| M535SAK304A0 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-10-30 |
| M535SAK303A0 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-10-30 |
| M535SAK302A0 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-10-30 |
| M535SAK301A0 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-10-30 |
| M535NX2000100 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2015-09-02 |
| M535NX200020 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX200010 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535SAK3070 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX2000110 | PUREFLOW SL KIT | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535SAK3060 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX200011EU0 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535SAK3050 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX20001A0 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535SAK3040 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX200060 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535SAK3030 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX20002EU0 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535SAK3020 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX200040 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535SAK3010 | Dialysate Sack (SAK) with Concentrate | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535PAK0010 | PUREFLOW SL PAK | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX20008EU0 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2015-09-01 |
| M535NX200080 | PUREFLOW SL | NXSTAGE MEDICAL, INC. | 2015-09-01 |