NxStage Medical Inc
Lawrence, MA, US
NXSTAGE MEDICAL, INC. appears in FDA device records in Lawrence, MA. FDA records list 51 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 39 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to NxStage Medical Inc carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Medisystems a NX Stage Companyenforcement report, recall
- NxStage MDS Corporationregistration, enforcement report, recall
510(k) clearance history
Showing 50 of 51FDA records hold 51 510(k) clearances for NxStage Medical Inc between 2001 and 2024. The busiest year on record is 2014, with 7. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 3 |
| 2002 | 5 |
| 2003 | 3 |
| 2004 | 5 |
| 2005 | 4 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 3 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 5 |
| 2014 | 7 |
| 2015 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | KDI | Substantially Equivalent | |
| K233213 | NxStage PureFlow Solution | KPO | Substantially Equivalent | |
| K230632 | VersiHD with GuideMe software | KDI | Substantially Equivalent | |
| K183158 | NxStage Cartridge Express with Speedswap | KDI | Substantially Equivalent | |
| K181991 | NxStage Connected Health System | FKP | Substantially Equivalent | |
| K171331 | NxStage System One | KDI | Substantially Equivalent | |
| K170469 | NxStage System One Plus | KDI | Substantially Equivalent | |
| K150472 | NxStage System One | ODN | Substantially Equivalent | |
| K143313 | NxStage Therapeutic Plasma Exchange (TPE) Cartridge | KDI | Substantially Equivalent | |
| K141752 | NXSTAGE SYSTEM ONE | ODN | Substantially Equivalent | |
| K134019 | MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO | FIE | Substantially Equivalent | |
| K140623 | NXSTAGE EXPRESS FLUID WARMER | FLA | Substantially Equivalent | |
| K140526 | NXSTAGE SYSTEM ONE | KDI | Substantially Equivalent | |
| K140571 | NXSTAGE PUREFLOW SL | FKR | Substantially Equivalent | |
| K133547 | NXSTAGE SYSTEM ONE WITH NXVIEW | KDI | Substantially Equivalent | |
| K132602 | STREAMLINE EXPRESS | KDI | Substantially Equivalent | |
| K131050 | NXSTAGE 1.6M2 DIALYZER | KDI | Substantially Equivalent | |
| K131739 | NXSTAGE CONNECTED HEALTH SYSTEM | FKP | Substantially Equivalent | |
| K130460 | NXSTAGE DOSING CALCULATOR | FKP | Substantially Equivalent | |
| K122051 | NXSTAGE SYSTEM ONE | KDI | Substantially Equivalent | |
| K123395 | NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS | KDI | Substantially Equivalent | |
| K113023 | STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER | KDI | Substantially Equivalent | |
| K111174 | NXSTAGE PUREFLOW SL | FKR | Substantially Equivalent | |
| K093069 | NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE | KDI | Substantially Equivalent | |
| K090255 | BLOOD TUBING SETS (STERILE FLUID PATH) | FJK | Substantially Equivalent | |
| K080919 | NXSTAGE PUREFLOW SL | FKR | Substantially Equivalent | |
| K080807 | BLOOD TUBING SETS (STERILE FLUID PATH) | FJK | Substantially Equivalent | |
| K081043 | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | KOC | Substantially Equivalent | |
| K071263 | NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 | KDI | Substantially Equivalent | |
| K061837 | NXSTAGE CARTRIDGE EXPRESS | KDI | Substantially Equivalent | |
| K060296 | NXSTAGE DIALYSATE PREPARATION MODULE | FKR | Substantially Equivalent | |
| K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION | KPO | Substantially Equivalent | |
| K050525 | NXSTAGE SYSTEM ONE | KDI | Substantially Equivalent | |
| K050727 | MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS | KDI | Substantially Equivalent | |
| K043436 | NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 | FKR | Substantially Equivalent | |
| K042089 | NX STAGE WATER PURIFICATION SYSTEM | FIP | Substantially Equivalent | |
| K042045 | NXSTAGE PUREFLOW-B SOLUTION | KPO | Substantially Equivalent | |
| K041424 | NXSTAGE SYSTEM ONE | KDI | Substantially Equivalent | |
| K040696 | MODIFICATION TO NXSTAGE SYSTEM ONE | KDI | Substantially Equivalent | |
| K040074 | ONEVIEW INTERFACE | FKP | Substantially Equivalent | |
| K033386 | NXSTAGE PUREFLOW SOLUTION | KPO | Substantially Equivalent | |
| K032356 | NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS | KDI | Substantially Equivalent | |
| K030470 | NXSTAGE SYSTEM ONE | FII | Substantially Equivalent | |
| K014152 | NXSTAGE CARTRIDGE EXPRESS | KDI | Substantially Equivalent | |
| K022913 | NXSTAGE PREMIXED DIALYSATE | KPO | Substantially Equivalent | |
| K020858 | NXSTAGE THERAPY SYSTEM | KDI | Substantially Equivalent | |
| K011269 | LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR | KDI | Substantially Equivalent | |
| K013655 | NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 | KPO | Substantially Equivalent | |
| K012832 | COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 | LGZ | Substantially Equivalent | |
| K012510 | MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM | KDI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003464075 | 3003464075 | NXSTAGE MEDICAL, INC. | 350 Merrimack St, LAWRENCE, MA 01843 US | 2026 | and 1 more, listed in full below |
| 2919260 | 2919260 | NxStage MDS Corporation | 350 Merrimack St, Lawrence, MA 01843 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- FLAMonitor, Temperature, Dialysis
- FIENeedle, Fistula
- FMINeedle, Hypodermic, Single Lumen
- FIBProtector, Transducer, Dialysis
- LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
- FOXStand, Infusion
- FKRSubsystem, Proportioning
- FIPSubsystem, Water Purification
- FIISystem, Dialysate Delivery, Sealed
- FKPSystem, Dialysate Delivery, Single Patient
- ODNUltrafiltration-Controlled Nocturnal Dialysate Delivery System
- LGZWarmer, Thermal, Infusion Fluid
Recall records
Showing 25 of 39| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1864-2025 | NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456. | Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment. | Class II | Open, Classified | |
| Z-2160-2024 | 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 | The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid. | Class II | Open, Classified | |
| Z-1191-2024 | NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload. | Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood. | Class II | Open, Classified | |
| Z-0697-2020 | 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 Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A; | There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes. | Class II | Terminated | |
| Z-1707-2019 | 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 hemodialysis. | Certain lots were mislabeled with incorrect product number. | Class II | Terminated | |
| Z-1706-2019 | 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 hemodialysis. | Certain lots were mislabeled with incorrect product number. | Class II | Terminated | |
| Z-0507-2019 | 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 dialysate during hemodialysis. | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin | Class II | Terminated | |
| Z-0506-2019 | 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 dialysate during hemodialysis. | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin | Class II | Terminated | |
| Z-0505-2019 | 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 dialysate during hemodialysis. | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin | Class II | Terminated | |
| Z-0504-2019 | 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 dialysate during hemodialysis. | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin | Class II | Terminated | |
| Z-0503-2019 | 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 dialysate during hemodialysis. | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin | Class II | Terminated | |
| Z-0502-2019 | 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 dialysate during hemodialysis. | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin | Class II | Terminated | |
| Z-0501-2019 | 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 dialysate during hemodialysis. | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin | Class II | Terminated | |
| Z-0500-2019 | 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 dialysate during hemodialysis. | PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin | Class II | Terminated | |
| Z-2793-2018 | 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 prior to administration. | There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of smoke, sparks, or flames coming from the Express Fluid Warmer since 2016. No adverse events have been reported. | Class II | Terminated | |
| Z-0811-2018 | 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 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories | May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product. | Class II | Terminated | |
| Z-1132-2018 | NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One | Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use. | Class II | Terminated | |
| Z-0337-2016 | NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4 | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed | Class II | Terminated | |
| Z-0336-2016 | NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis. | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed | Class II | Terminated | |
| Z-0335-2016 | NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis. | Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed | Class II | Terminated | |
| Z-0327-2016 | NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A | Ultrafiltration (UF) Volume software error inaccurate fluid removal | Class II | Terminated | |
| Z-0326-2016 | NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 | Ultrafiltration (UF) Volume software error inaccurate fluid removal | Class II | Terminated | |
| Z-1861-2014 | 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) 50 | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | Class II | Terminated | |
| Z-1860-2014 | 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) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch. | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | Class II | Terminated | |
| Z-1859-2014 | 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) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified water prepared by NxStage PureFlow SL Dialysate Preparation System to prepare a batch of dialysate for use with the NxStage System One. SAKs are packaged in a case containing two SAKs. SAK product SKUs vary in the dialysate concentrate and volume of the final dialysate batch. | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain