Nxstage Medical, Inc.
Nxstage Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2024, with 31 FDA device recalls on record.
Top product codes for Nxstage Medical, Inc.
- KDI — Gastroenterology, Urology
- KPO — Gastroenterology, Urology
- FKR — Gastroenterology, Urology
- FKP — Gastroenterology, Urology
- FJK — Gastroenterology, Urology
- ODN — Gastroenterology, Urology
- FIE — Gastroenterology, Urology
- FII — Gastroenterology, Urology
- FIP — Gastroenterology, Urology
- FLA — Gastroenterology, Urology
FDA recalls by Nxstage Medical, Inc.
10 most recent of 31- 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.
- 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
- 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;
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Nxstage Medical, Inc.
- K232803 — NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
- K233213 — NxStage PureFlow Solution
- K230632 — VersiHD with GuideMe software
- K183158 — NxStage Cartridge Express with Speedswap
- K181991 — NxStage Connected Health System
- K171331 — NxStage System One
- K170469 — NxStage System One Plus
- K150472 — NxStage System One
- K143313 — NxStage Therapeutic Plasma Exchange (TPE) Cartridge
- K141752 — NXSTAGE SYSTEM ONE
- K134019 — MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
- K140623 — NXSTAGE EXPRESS FLUID WARMER
- K140526 — NXSTAGE SYSTEM ONE
- K140571 — NXSTAGE PUREFLOW SL
- K133547 — NXSTAGE SYSTEM ONE WITH NXVIEW
- K132602 — STREAMLINE EXPRESS
- K131050 — NXSTAGE 1.6M2 DIALYZER
- K131739 — NXSTAGE CONNECTED HEALTH SYSTEM
- K130460 — NXSTAGE DOSING CALCULATOR
- K122051 — NXSTAGE SYSTEM ONE
- K123395 — NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
- K113023 — STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
- K111174 — NXSTAGE PUREFLOW SL
- K093069 — NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
- K090255 — BLOOD TUBING SETS (STERILE FLUID PATH)
- K080919 — NXSTAGE PUREFLOW SL
- K080807 — BLOOD TUBING SETS (STERILE FLUID PATH)
- K081043 — LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
- K071263 — NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
- K061837 — NXSTAGE CARTRIDGE EXPRESS
- K060296 — NXSTAGE DIALYSATE PREPARATION MODULE
- K053286 — MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
- K050525 — NXSTAGE SYSTEM ONE
- K050727 — MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
- K043436 — NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
- K042089 — NX STAGE WATER PURIFICATION SYSTEM
- K042045 — NXSTAGE PUREFLOW-B SOLUTION
- K041424 — NXSTAGE SYSTEM ONE
- K040696 — MODIFICATION TO NXSTAGE SYSTEM ONE
- K040074 — ONEVIEW INTERFACE
- K033386 — NXSTAGE PUREFLOW SOLUTION
- K032356 — NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
- K030470 — NXSTAGE SYSTEM ONE
- K014152 — NXSTAGE CARTRIDGE EXPRESS
- K022913 — NXSTAGE PREMIXED DIALYSATE
- K020858 — NXSTAGE THERAPY SYSTEM
- K011269 — LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR
- K013655 — NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
- K012832 — COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200
- K012510 — MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
- K001283 — LIFEMATE HEMOFILTRATION SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.