Company ยท US
Nxstage Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2024. Name variants (Inc, Corp, punctuation) are merged.
51510(k) clearances (0 in 12 months)
36recalls (0 in 12 months)
36recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 36 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 21 |
| FKR | Subsystem, Proportioning | 15 |
| FKP | System, Dialysate Delivery, Single Patient | 4 |
| FJK | Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | 2 |
| ODN | Ultrafiltration-Controlled Nocturnal Dialysate Delivery System | 2 |
| FIE | Needle, Fistula | 1 |
| FII | System, Dialysate Delivery, Sealed | 1 |
| FIP | Subsystem, Water Purification | 1 |
| FLA | Monitor, Temperature, Dialysis | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 |
| LGZ | Warmer, Thermal, Infusion Fluid | 1 |
| PEV | Dialysis Administration Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 2024 | K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) Nxstage Medical, Inc. | KDI |
| Jan 18, 2024 | K233213 | NxStage PureFlow Solution Nxstage Medical, Inc. | KPO |
| Aug 11, 2023 | K230632 | VersiHD with GuideMe software Nxstage Medical, Inc. | KDI |
| Aug 9, 2019 | K183158 | NxStage Cartridge Express with Speedswap Nxstage Medical, Inc. | KDI |
| Sep 26, 2018 | K181991 | NxStage Connected Health System Nxstage Medical, Inc. | FKP |
| Aug 24, 2017 | K171331 | NxStage System One Nxstage Medical, Inc. | KDI |
| May 9, 2017 | K170469 | NxStage System One Plus Nxstage Medical, Inc. | KDI |
| Jun 4, 2015 | K150472 | NxStage System One Nxstage Medical, Inc. | ODN |
| Mar 20, 2015 | K143313 | NxStage Therapeutic Plasma Exchange (TPE) Cartridge Nxstage Medical, Inc. | KDI |
| Dec 19, 2014 | K141752 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | ODN |
| Sep 11, 2014 | K134019 | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO Nxstage Medical, Inc. | FIE |
| Jun 16, 2014 | K140623 | NXSTAGE EXPRESS FLUID WARMER Nxstage Medical, Inc. | FLA |
| May 19, 2014 | K140526 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | KDI |
| May 15, 2014 | K140571 | NXSTAGE PUREFLOW SL Nxstage Medical, Inc. | FKR |
| Mar 3, 2014 | K133547 | NXSTAGE SYSTEM ONE WITH NXVIEW Nxstage Medical, Inc. | KDI |
| Feb 4, 2014 | K132602 | STREAMLINE EXPRESS Nxstage Medical, Inc. | KDI |
| Dec 27, 2013 | K131050 | NXSTAGE 1.6M2 DIALYZER Nxstage Medical, Inc. | KDI |
| Oct 10, 2013 | K131739 | NXSTAGE CONNECTED HEALTH SYSTEM Nxstage Medical, Inc. | FKP |
| Jul 11, 2013 | K130460 | NXSTAGE DOSING CALCULATOR Nxstage Medical, Inc. | FKP |
| Apr 23, 2013 | K122051 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | KDI |
| Mar 7, 2013 | K123395 | NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS Nxstage Medical, Inc. | KDI |
| Dec 21, 2012 | K113023 | STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER Nxstage Medical, Inc. | KDI |
| Sep 19, 2011 | K111174 | NXSTAGE PUREFLOW SL Nxstage Medical, Inc. | FKR |
| Oct 23, 2010 | K093069 | NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE Nxstage Medical, Inc. | KDI |
| Feb 10, 2009 | K090255 | BLOOD TUBING SETS (STERILE FLUID PATH) Nxstage Medical, Inc. | FJK |
| Oct 15, 2008 | K080919 | NXSTAGE PUREFLOW SL Nxstage Medical, Inc. | FKR |
| Jul 18, 2008 | K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) Nxstage Medical, Inc. | FJK |
| Jul 7, 2008 | K081043 | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT Nxstage Medical, Inc. | KOC |
| Aug 24, 2007 | K071263 | NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 Nxstage Medical, Inc. | KDI |
| Jul 31, 2006 | K061837 | NXSTAGE CARTRIDGE EXPRESS Nxstage Medical, Inc. | KDI |
| Mar 31, 2006 | K060296 | NXSTAGE DIALYSATE PREPARATION MODULE Nxstage Medical, Inc. | FKR |
| Dec 22, 2005 | K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION Nxstage Medical, Inc. | KPO |
| Jun 24, 2005 | K050525 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | KDI |
| Jun 13, 2005 | K050727 | MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS Nxstage Medical, Inc. | KDI |
| Mar 17, 2005 | K043436 | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 Nxstage Medical, Inc. | FKR |
| Nov 24, 2004 | K042089 | NX STAGE WATER PURIFICATION SYSTEM Nxstage Medical, Inc. | FIP |
| Aug 27, 2004 | K042045 | NXSTAGE PUREFLOW-B SOLUTION Nxstage Medical, Inc. | KPO |
| Jul 2, 2004 | K041424 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | KDI |
| May 26, 2004 | K040696 | MODIFICATION TO NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | KDI |
| Apr 8, 2004 | K040074 | ONEVIEW INTERFACE Nxstage Medical, Inc. | FKP |
| Nov 26, 2003 | K033386 | NXSTAGE PUREFLOW SOLUTION Nxstage Medical, Inc. | KPO |
| Oct 28, 2003 | K032356 | NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS Nxstage Medical, Inc. | KDI |
| Jul 7, 2003 | K030470 | NXSTAGE SYSTEM ONE Nxstage Medical, Inc. | FII |
| Dec 11, 2002 | K014152 | NXSTAGE CARTRIDGE EXPRESS Nxstage Medical, Inc. | KDI |
| Oct 21, 2002 | K022913 | NXSTAGE PREMIXED DIALYSATE Nxstage Medical, Inc. | KPO |
| Apr 17, 2002 | K020858 | NXSTAGE THERAPY SYSTEM Nxstage Medical, Inc. | KDI |
| Mar 4, 2002 | K011269 | LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR Nxstage Medical, Inc. | KDI |
| Feb 4, 2002 | K013655 | NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 Nxstage Medical, Inc. | KPO |
| Oct 24, 2001 | K012832 | COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 Nxstage Medical, Inc. | LGZ |
| Oct 19, 2001 | K012510 | MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM Nxstage Medical, Inc. | KDI |
Newest 50 of 51.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2025 | NxStage Medical Inc NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456. Open, Classified |
KPO | K053286 |
| Jun 20, 2024 | NxStage Medical Inc NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456 Open, Classified |
KPO | K053286 |
| Aug 27, 2019 | NxStage Medical, Inc. Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices:
1) NxStage One, Model NX1000-1;
2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A;
3) NxStage One, Model N Terminated |
PEV | K050525 |
| Apr 11, 2019 | NxStage Medical, Inc. NxStage PureFlow B Solution, REF RFP-401, M535RPF4010
NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialys Terminated |
KPO | K053286 |
| Apr 11, 2019 | NxStage Medical, Inc. NxStage PureFlow B Solution, REF RFP-400, M535RFP4000
Product NxStage PureFlow B Solution is indicated for use with renal
replacement therapy systems that utilize sterile premixed dialysate during he Terminated |
KPO | K053286 |
| Oct 17, 2018 | NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dia Terminated |
KPO | K053286 |
| Oct 17, 2018 | NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dia Terminated |
KPO | K053286 |
| Oct 17, 2018 | NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysa Terminated |
KPO | K053286 |
| Oct 17, 2018 | NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysa Terminated |
KPO | K053286 |
| Oct 17, 2018 | NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialys Terminated |
KPO | K053286 |
| Oct 17, 2018 | NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysa Terminated |
KPO | K053286 |
| Oct 17, 2018 | NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis
NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysa Terminated |
KPO | K053286 |
| Oct 17, 2018 | NxStage Medical, Inc. NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis.
NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialy Terminated |
KPO | K053286 |
| Jun 11, 2018 | NxStage Medical, Inc. NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A)
Product Usage:
The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prio Terminated |
KDI | K071263 |
| Jan 29, 2018 | NxStage Medical, Inc. NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 U Terminated |
FKR | K140571 |
| Nov 10, 2017 | NxStage Medical, Inc. NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One Terminated |
KPO | K053286 |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler -High Permeability Hemodialysis System
Model no. NX1000-4 Terminated |
KDI | K140526 |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler - Model no. NX1000-3-A (OUS).
For home hemodialysis. Terminated |
KDI | K140526 |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler - Model no. NX1000-3.
For home hemodialysis. Terminated |
KDI | K122051 |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler (High Permeability Hemodialysis System)
Model no. NX1000-5-A Terminated |
KDI | K133547 |
| Oct 29, 2015 | NxStage Medical, Inc. NxStage System One S Cycler (High Permeability Hemodialysis System)
Model no. NX1000-5 Terminated |
KDI | K133547 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-407
Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,
Chloride 105, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-307
Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,
Chloride 105, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-306
Lactate 45, Potassium 2, Sodium 140, Calcium 3, Magnesium 1,
Chloride 101, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-305
Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1
Chloride 100, Glucose (mg/dL) 100
Batch Size (liters) 40 Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-304
Lactate 45, Potassium 2, Sodium 140, Calcium 3,Magnesium 1,
Chloride 101, Glucose (mg/dL) 100
Batch Size (liters) 6 Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-303
Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 100m
Chloride 100m, Glucose (mg/dL) 100
Batch Size (liter Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-302
Lactate , 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100,
Batch Size (lite Terminated |
FKR | K111174 K140571 |
| Jun 24, 2014 | NxStage Medical, Inc. NxStage Dialysate Sack (SAK) with Concentrate
for Use with PureFlow SL
REF: SAK-301
Lactate 45, Potassium 1, Sodium 140, Calcium 3, Magnesium 1,
Chloride 100, Glucose (mg/dL) 100
Batch Size (liters) Terminated |
FKR | K111174 K140571 |
| Feb 24, 2014 | NxStage Medical, Inc. NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags.
The NxStage PureFlow-B Solution is indicated for use with renal replace Terminated |
KPO | K053286 |
| May 2, 2013 | NxStage Medical, Inc. NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case
The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premix Terminated |
KPO | K042045 |
| Jan 20, 2012 | NxStage Medical, Inc. NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx
The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate Terminated |
FKR | K080919 K111174 |
| Sep 20, 2007 | NxStage Medical, Inc. NxStage Cartridge Express, CAR-170, for hemodialysis. Terminated |
KDI | K050525 K061837 |
| Jul 20, 2004 | NxStage Medical, Inc. NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model # CAR-154 Cartridge Express, 6 units per case. Terminated |
KDI | K040696 |
| Jul 20, 2004 | NxStage Medical, Inc. NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-153 Cartridge Express. 6 units per case. Terminated |
KDI | K040696 |
| Jul 20, 2004 | NxStage Medical, Inc. NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case. Terminated |
KDI | K040696 |