ClearanceBrief
Company

Fresenius Medical Care Holdings, Inc.

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
162recalls (4 in 12 months)
148recalls that name a 510(k)

Product codes

CodeDeviceRecords
KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)59
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System53
FKXSystem, Peritoneal, Automatic Delivery10
KDJSet, Administration, For Peritoneal Dialysis, Disposable10
FIPSubsystem, Water Purification8
JKATubes, Vials, Systems, Serum Separators, Blood Collection6
ONWHemodialysis System For Home Use4
FMFSyringe, Piston3
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2
KOCAccessories, Blood Circuit, Hemodialysis2
QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure2
FJIDialyzer, Capillary, Hollow Fiber1
ODXAutonomous Extracorporeal Blood Leak Detector/Alarm1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Jul 8, 2026Fresenius Medical Care Holdings, Inc.
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD/HDF Standard B
Open, Classified		 KDIK243505
Jun 11, 2026Fresenius Medical Care Holdings, Inc.
Bicarby Dialysate; Model number: RFP-400-G;
Open, Classified		 KPOK243786
Jun 5, 2026Fresenius Medical Care Holdings, Inc.
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
Open, Classified		 KPOK233950
K243786
Dec 17, 2025Fresenius Medical Care Holdings, Inc.
5008X CAREsystem +CLiC +CDX;
Open, Classified		 KDIK243505
Oct 3, 2025Fresenius Medical Care Holdings, Inc.
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)
Open, Classified		 FJIK162488
Jun 18, 2025Fresenius Medical Care Holdings, Inc.
5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline, Model Number: 03-5100-7. b. 5008X Standard HDF Bloodline w/CLIC, Model Number:
Open, Classified		 KDIK231534
Jan 3, 2025Fresenius Medical Care Holdings, Inc.
Dialyzer Optiflux 160NRe
Open, Classified		 KDIK162488
Sep 11, 2024Fresenius Medical Care Holdings, Inc.
Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or 191389) with firmware version S005 installed in 2008 Series Hemodialysis Machines with Part Numbers 190573, 190713, 190766, 190858, 19
Open, Classified		 KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified		 KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified		 KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified		 KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified		 KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified		 KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified		 KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified		 KDINone listed
Jul 11, 2024Fresenius Medical Care Holdings, Inc.
190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Open, Classified		 KDINone listed
Jun 13, 2024Fresenius Medical Care Holdings, Inc.
US AquaA 900H-Typ USA-3 x 208v-Intended for the purification of water to be used for hemodialysis Vivonic Part Numbers: G02020110 Fresenius Part Number: 24-090A-1
Open, Classified		 FIPK143617
May 17, 2024Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191130 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A
Open, Classified		 KDIK173972
K222952 +1
May 17, 2024Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Open, Classified		 KDIK173972
K222952 +1
May 17, 2024Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Open, Classified		 KDIK173972
K222952 +1
May 17, 2024Fresenius Medical Care Holdings, Inc.
2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Open, Classified		 KDIK173972
K222952 +1
May 17, 2024Fresenius Medical Care Holdings, Inc.
Blood Pump Rotor, Model Number: F40015481 Rev A
Open, Classified		 KDINone listed
May 15, 2024Fresenius Medical Care Holdings, Inc.
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and ph
Open, Classified		 QJZK191407
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Catheter Ext. 6 in
Open, Classified		 KDJK022412
K173593
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 18 in
Open, Classified		 KDJK022412
K173593
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 12 in
Open, Classified		 KDJK022412
K173593
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Adapter 4 in
Open, Classified		 KDJK022412
K173593
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Safe Lock Catheter Ext. 12 in
Open, Classified		 KDJK022412
K173593
Dec 26, 2023Fresenius Medical Care Holdings, Inc.
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
Open, Classified		 FKXK222318
Dec 7, 2023Fresenius Medical Care Holdings, Inc.
Stay Safe Cap
Open, Classified		 KDJK083542
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
Open, Classified		 KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. W/O CDX BLUESTAR
Open, Classified		 KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. CDX W/BIBAG BLUESTAR
Open, Classified		 KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T HD SYS. CDX BLUESTAR
Open, Classified		 KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T GEN 2 Bibag without CDX
Open, Classified		 KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis System w/Bibag
Open, Classified		 KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis System without CDX
Open, Classified		 KDIK150708
K173972 +1
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Open, Classified		 FMFK050999
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Open, Classified		 FMFK050999
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Open, Classified		 FMFK050999
Oct 6, 2023Fresenius Medical Care Holdings, Inc.
2008T Hemodialysis SYS, with CDX
Open, Classified		 KDIK150708
K173972 +1
Dec 20, 2022Fresenius Medical Care Holdings, Inc.
2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and chronic dialysis therapy in a healthcare facility Models: (1) 190713 2008T HEMODIALYSIS SYS., with CDX; (2) 190766 200
Open, Classified		 KDIK173972
Nov 4, 2022Fresenius Medical Care Holdings, Inc.
NaturaLyte Liquid Acid concentrate, Part Number 08-0231-4, four (4) one-gallon bottles per bottle case. For dialysis.
Open, Classified		 KPOK070177
Sep 19, 2022Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
Open, Classified		 FIPK143617
Sep 19, 2022Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
Open, Classified		 FIPK143617
Jul 25, 2022Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US
Open, Classified		 FIPK143617
Jul 25, 2022Fresenius Medical Care Holdings, Inc.
AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US
Open, Classified		 FIPK143617
Jun 1, 2022Fresenius Medical Care Holdings, Inc.
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Terminated		 KPOK192017
May 31, 2022Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 3.0K 3.0Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-3301-2
Open, Classified		 KPOK192017
May 31, 2022Fresenius Medical Care Holdings, Inc.
NATURALYTE Liquid Acid 2.0K 2.5Ca- indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure Part Number: 08-2251-0
Open, Classified		 KPOK192017

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