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510(k) K053286 · KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)

MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

Applicant	Nxstage Medical, Inc., Lawrence MA, US
Decision	Substantially Equivalent, Dec 22, 2005
Received	Nov 25, 2005
Type	Special
FDA record	Open on fda.gov

Recalls that name K053286

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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
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	None listed
Nov 10, 2017	NxStage Medical, Inc. NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One Terminated	KPO	None listed
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	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.