Fresenius Medical Care Renal Therapies Group, LLC

FDA Device Registration & Listing · Waltham, MA, US · Registration 1225714

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1225714
FEI Number
3001451489
Entity Name
Fresenius Medical Care Renal Therapies Group, LLC
City/State/Country
Waltham, MA, US
Establishment Address
920 WINTER STREET, Waltham, MA 02451, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Fresenius Medical Care Renal Therapies Group, LLC (Owner Number: 9030510)
Owner / Operator Contact Address
920 WINTER STREET, --, Waltham, MA 02451, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K822550
PMA Number
N/A

All Registered Proprietary Names

Liberty Cycler Set StaySafe Handi-Tool StaySafe Organizer StaySafe Clip StaySafe Organizer Holder Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set Bicarby CATHETER ADAPTER SEALING CAP NaturaLyte Liquid Acid Concentrate Citrasate Liquid Acid Concentrate Fresenius Sterile Stay Safe Cap Crit-Line Clip (CLiC) Blood Chamber 2008T BlueStar Hemodialysis Machine AquaBplus 2008T BlueStar Hemodialysis Machine PACK-PD Peritoneal Dialysis Urea Kinetic Modeling Software Program 5008X CAREsystem Hemoflow F4 Dialyzer Hemoflow F3 Dialyzer Granuflo Dry Acid Concentrate Citrasate Dry Acid Concentrate Combilines Hemodialysis Blood Tubing Set Fresenius Priming Set with Needless Access Port Optiflux F180NR Dialyzer 4 LEAD ECO PREFILLED W/SNAP DISCONNECT 2008K@HOME HEMODIALYSIS MACHINE CombiSet - 2008 Series Home Hemodialysis with Prime Bag 2008K Hemodialysis Machine 2008T Hemodialysis Machine 2008K@home Hemodialysis Machine AquaA CombiSet Hemodialysis Blood Tubing Set 2008K@Home HD Machine w/WWD (WETALERT) AquaC UNO H CritLine IV System Citrasate Liquid Acid Concentrate NaturaLyte Liquid Acid Concentrate Fresenius Bloodlines Patient Connector (HemaClip) Fresenius Liberty Select Cycler Aqua C UNO H stay safe Drain Set Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors bibag Bicarby Dialysate AquaA Fresenius Standalone Access Flow Reserving Connector NaturaLyte Dry Bicarbonate Concentrate CombiSet SMARTECH Hemodialysis Blood Tubing Sets Liberty Drain Line Fresenius Combilines Blood Tubing Set APD Luer Lock Adapter Optiflux F160NR, F180NR, F200NR, F250NR Dialyzers StaySafe to Luer-Lock Adapater StaySafe Catheter Ext Set with Luer-Lock, 12 StaySafe Catheter Ext Set with Luer-Lock, 6 StaySafe Catheter Ext Set with Safe-Lock, 12 StaySafe Catheter Ext Set with Luer-Lock, 18 5008X Hemodialysis System stay•safe Catheter Extension Sets Bicarby Dialysate AquaBplus, AquaB LITE 2008T BlueStar Hemodialysis Machine Safe-Lock Universal Connector 2008K2 Hemodialysis Machine 2008T BlueStar Hemodialysis Machine Liberty Select Cycler Granuflo Mixing System Fresenius Liberty Select Cycler Safe-Lock catheter adapter Co-Pack II

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2018-05-15
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2012-06-27
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2024-09-24
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2009-07-16
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2022-11-21
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2008-12-30
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2016-01-26
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2022-11-16
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2020-03-13
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2018-05-15
KPF System, Dialysate Delivery, Semi-Automatic, Peritoneal Gastroenterology, Urology Class 2 876.5630 2008-03-18
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2025-06-03
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2025-06-03
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2025-06-03
NII Disinfectant, Dialysate Delivery System Gastroenterology, Urology Class 2 876.5860 2025-06-03
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-06-03
FJI Dialyzer, Capillary, Hollow Fiber Gastroenterology, Urology Class 2 876.5820 2019-08-27
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2020-05-14
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2008-03-05
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2008-01-08
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2020-09-22
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2009-07-16
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2014-08-07
ODX Autonomous Extracorporeal Blood Leak Detector/Alarm Gastroenterology, Urology Class 2 876.5820 2011-05-04
ONW Hemodialysis System For Home Use Gastroenterology, Urology Class 2 876.5860 2011-05-04
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2016-01-26
ONW Hemodialysis System For Home Use Gastroenterology, Urology Class 2 876.5860 2016-01-26
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2022-11-21
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2023-06-14
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2014-08-07
ODX Autonomous Extracorporeal Blood Leak Detector/Alarm Gastroenterology, Urology Class 2 876.5820 2014-08-07
ONW Hemodialysis System For Home Use Gastroenterology, Urology Class 2 876.5860 2014-08-07
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2026-03-18
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2015-04-29
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2020-05-08
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2008-01-08
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2013-12-12
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2018-05-30
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2020-03-13
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2018-02-15
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2017-06-15
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2025-04-16
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2026-03-18
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2008-01-08
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2020-03-02
KOC Accessories, Blood Circuit, Hemodialysis Gastroenterology, Urology Class 2 876.5820 2020-09-22
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2020-09-22
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2008-01-08
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2008-01-08
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2015-02-27
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2017-05-09
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2018-05-24
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2024-03-01
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve Gastroenterology, Urology Class 2 876.5820 2024-03-01
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2024-03-01
NII Disinfectant, Dialysate Delivery System Gastroenterology, Urology Class 2 876.5860 2024-03-01
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2013-09-20
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2025-09-10
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2025-11-26
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2025-02-14
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2025-06-27
KDJ Set, Administration, For Peritoneal Dialysis, Disposable Gastroenterology, Urology Class 2 876.5630 2015-06-25
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2017-09-26
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology Class 2 876.5860 2024-02-15
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2023-01-30
KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder) Gastroenterology, Urology Class 2 876.5820 2008-01-08
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2017-09-26
FKX System, Peritoneal, Automatic Delivery Gastroenterology, Urology Class 2 876.5630 2009-07-16

Official Correspondent

Rachel Lloyd

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fresenius Medical Care Renal Therapies Group, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3023981687 Erika of Texas Pharr, TX, US
3012364195 Fresenius Medical Care de Mexico Zapopan Jalisco, MX
3031565407 Erika de Reynosa, S.A. de C.V. CD, Reynosa Tamaulipas, MX
3005578748 Haemotec, a division of Fresenius Medical Care Canada Inc. VAUDREUIL-DORION Quebec, CA
3013546115 Fresenius USA Manufacturing, Inc. Knoxville, TN, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K822361 Travenol Laboratories, S.A. DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 1982-08-16
K933687 R & D Batteries, Inc. R & D BATTERIES,INC. PART NUMBERS 5164, 5272, 5260 1994-02-09
K811830 Cordis Corp. C-DAK DUO-FLUX ARTIFICIAL KIDNEY 1981-09-21
K070320 Edwards Lifesciences Services GmbH EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01 2007-06-07
K150880 Outset Medical Tablo Console with Wireless Capability 2015-05-01

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024 Fresenius Medical Care Holdings, Inc. 2
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Z-0007-2024 Fresenius Medical Care Holdings, Inc. 2
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Z-0017-05 Fresenius Medical Care North America 2
Fresenius Peritoneal Dialysis Premier Luer Lock Transfer Set 8'', Sterile with Female Safe Lock Connector Luer Lock and Slide Clamp Catalog Number: 050-30034
Z-0028-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis SYS, with CDX
Z-0029-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System without CDX
Z-0030-2024 Fresenius Medical Care Holdings, Inc. 2
2008T Hemodialysis System w/Bibag
Z-0031-2024 Fresenius Medical Care Holdings, Inc. 2
2008T GEN 2 Bibag without CDX
Z-0032-2024 Fresenius Medical Care Holdings, Inc. 2
2008T HD SYS. CDX BLUESTAR
Z-0033-2024 Fresenius Medical Care Holdings, Inc. 2
2008T HD SYS. CDX W/BIBAG BLUESTAR
Z-0034-2024 Fresenius Medical Care Holdings, Inc. 2
2008T HD SYS. W/O CDX BLUESTAR
Z-0035-2024 Fresenius Medical Care Holdings, Inc. 2
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Z-0041-2026 Fresenius Medical Care Holdings, Inc. 2
Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1225714. Last updated year: 2026. Please use registration number 1225714 when referencing this establishment in official correspondence.
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