Data / Medical devices / United States / Nxstage Medical, Inc.
Nxstage Medical, Inc.: FDA-registered device maker in Lawrence, MA, United States, 24 510(k) clearances
Nxstage Medical, Inc. is registered with the FDA (registration 3003464075) in Lawrence, MA, United States. It lists 11 device types. The FDA files 24 510(k) clearances under its listings, the newest dated May 15, 2026. 18 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003464075
- Address
- 350 Merrimack St, Lawrence, MA, United States, 01843
- Owner or operator
- Fresenius Medical Care Holdings, Inc. (10061218)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- September 20, 2019
- Registered through
- 2026
- Brand names listed
- NxStage Cartridge Express, VersiHD with GuideMe Software, ViraGuard Viral Blocking Patient Transducer Protector
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Monitor, Temperature, Dialysis | FLA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Needle, Fistula | FIE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Protector, Transducer, Dialysis | FIB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Separator, Automated, Blood Cell And Plasma, Therapeutic | LKN | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Subsystem, Proportioning | FKR | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 15, 2026 | K252377 | NxStage System One with NxView | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| March 14, 2024 | K232803 | NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) | KDI | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| January 18, 2024 | K233213 | NxStage PureFlow Solution | KPO | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| August 11, 2023 | K230632 | VersiHD with GuideMe software | KDI | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| May 9, 2017 | K170469 | NxStage System One Plus | KDI | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| March 20, 2015 | K143313 | NxStage Therapeutic Plasma Exchange (TPE) Cartridge | KDI | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| June 16, 2014 | K140623 | NXSTAGE EXPRESS FLUID WARMER | FLA | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| May 19, 2014 | K140526 | NXSTAGE SYSTEM ONE | KDI | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| May 15, 2014 | K140571 | NXSTAGE PUREFLOW SL | FKR | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| March 3, 2014 | K133547 | NXSTAGE SYSTEM ONE WITH NXVIEW | KDI | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| April 23, 2013 | K122051 | NXSTAGE SYSTEM ONE | KDI | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| September 19, 2011 | K111174 | NXSTAGE PUREFLOW SL | FKR | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| July 7, 2008 | K081043 | LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT | KOC | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| August 24, 2007 | K071263 | NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500 | KDI | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| December 22, 2005 | K053286 | MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION | KPO | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| June 24, 2005 | K050525 | NXSTAGE SYSTEM ONE | KDI | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| November 26, 2003 | K033386 | NXSTAGE PUREFLOW SOLUTION | KPO | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| October 24, 2001 | K012832 | COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200 | LGZ | Substantially Equivalent | Nxstage Medical, Inc. | accessdata.fda.gov |
| January 6, 2000 | K990803 | MEDISYSTEMS BUTTONHOLE NEEDLE SETS | FIE | Substantially Equivalent | Medisystems Corp. | accessdata.fda.gov |
| November 25, 1998 | K983076 | MEDISYSTEMS TRANSDUCER PROTECTOR | FIB | Substantially Equivalent | Medisystems Corp. | accessdata.fda.gov |
| August 18, 1997 | K971860 | MEDISYSTEMS DIALYSIS PRIMING SETS | KOC | Substantially Equivalent | Medisystems Corp. | accessdata.fda.gov |
| February 18, 1994 | K932074 | MEDISYSTEMS APHERESIS NEEDLE WITH GUARD | FIE | Substantially Equivalent | Medisystems Corp. | accessdata.fda.gov |
| June 20, 1991 | K910734 | MEDISYSTEMS HEMODIALYSIS FISTULA SET | FIE | Substantially Equivalent | Medisystems Corp. | accessdata.fda.gov |
| June 6, 1991 | K910733 | MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE | FMI | Substantially Equivalent | Medisystems Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 28, 2025 | 96730 | Class II | Ongoing | 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. | accessdata.fda.gov |
| May 14, 2024 | 94641 | Class II | Ongoing | 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 fl | accessdata.fda.gov |
| January 29, 2024 | 93886 | Class II | Ongoing | 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 ov | 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. | accessdata.fda.gov |
| August 27, 2019 | 83706 | Class II | Terminated | 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 | 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. | accessdata.fda.gov |
| April 11, 2019 | 82693 | Class II | Terminated | 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. | accessdata.fda.gov |
| October 17, 2018 | 81445 | Class II | Terminated | 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 hemodialysi | 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 | accessdata.fda.gov |
| June 11, 2018 | 80512 | Class II | Terminated | 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. | accessdata.fda.gov |
| January 29, 2018 | 79185 | Class II | Terminated | 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) | 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. | accessdata.fda.gov |
| November 10, 2017 | 79276 | Class II | Terminated | 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 f | accessdata.fda.gov |
| October 29, 2015 | 72554 | Class II | Terminated | 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 | accessdata.fda.gov |
| October 29, 2015 | 72543 | Class II | Terminated | NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5 | Ultrafiltration (UF) Volume software error inaccurate fluid removal | accessdata.fda.gov |
| May 14, 2014 | 68354 | Class II | Terminated | 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) 60 The SAK is one of | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification | accessdata.fda.gov |
| January 24, 2014 | 67405 | Class II | Terminated | 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 replacement therapy systems tha | Mislabeled product. | accessdata.fda.gov |
| March 18, 2013 | 64820 | Class II | Terminated | 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 premixed dialysate during he | Product may be mislabeled. | accessdata.fda.gov |
| December 20, 2012 | 63959 | Class II | Terminated | Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a const | A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". | accessdata.fda.gov |
| December 14, 2011 | 60807 | Not yet classified | Terminated | 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 for use during hemodi | Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System | accessdata.fda.gov |
| July 27, 2007 | 38546 | Not yet classified | Terminated | NxStage Cartridge Express, CAR-170, for hemodialysis. | Potential for dialysate leaks from the cartridge during treatment. | accessdata.fda.gov |
| April 14, 2004 | 29268 | Not yet classified | Terminated | NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case. | Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate | accessdata.fda.gov |
Compare with other makers
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- All makers of Accessories, Blood Circuit, Hemodialysis
- All makers of Warmer, Thermal, Infusion Fluid
- All makers of Needle, Hypodermic, Single Lumen
Updated May 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.