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Panels › Gastroenterology, Urology › Product code FJK · Class 2

Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Regulation 876.5820

2510(k)s in 12 months (77 all time)
7recalls in 12 months (36 all time)
35recalls that name a 510(k)
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Top companies in FJK

DateFirm and productCodeLinked 510(k)
Sep 18, 2026Fresenius Medical Care Renal Therapies Group, LLC
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Open, Classified
FJKK213992
Apr 15, 2026B Braun Medical Inc
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Open, Classified
FJKK080807
Apr 15, 2026B Braun Medical Inc
B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705.
Open, Classified
FJKK080807
Apr 15, 2026B Braun Medical Inc
B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L.
Open, Classified
FJKK080807
Apr 15, 2026B Braun Medical Inc
B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA.
Open, Classified
FJKK080807
Apr 15, 2026B Braun Medical Inc
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096
Open, Classified
FJKK080807
Apr 15, 2026B Braun Medical Inc
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
Open, Classified
FJKK080807
Oct 22, 2025B BRAUN MEDICAL INC
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalog Number: SL-2010M2096 Software Version: N/A Product Description: STREAMLINE BLOODLINE SET FOR DIALOG
Open, Classified
FJKK080807
Sep 19, 2024B Braun Medical Inc
STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
Open, Classified
FJKK080807
Sep 19, 2024B Braun Medical Inc
STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096
Open, Classified
FJKK080807
Sep 19, 2024B Braun Medical Inc
STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W
Open, Classified
FJKK080807
Sep 19, 2024B Braun Medical Inc
STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095L
Open, Classified
FJKK080807
Sep 19, 2024B Braun Medical Inc
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA
Open, Classified
FJKK080807
Sep 19, 2024B Braun Medical Inc
STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D
Open, Classified
FJKK080807
Sep 19, 2024B Braun Medical Inc
SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095
Open, Classified
FJKK080807
Apr 14, 2021Baxter Healthcare Corporation
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Terminated
FJKK070414
Dec 30, 2020Baxter Healthcare Corporation
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dia
Open, Classified
FJKK100364
Dec 30, 2020Baxter Healthcare Corporation
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Deliv
Open, Classified
FJKK070414
Dec 30, 2020Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems
Open, Classified
FJKK070414
Dec 30, 2020Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems
Open, Classified
FJKK070414
Dec 30, 2020Baxter Healthcare Corporation
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Open, Classified
FJKK070414
Dec 30, 2020Baxter Healthcare Corporation
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Open, Classified
FJKK070414
Aug 31, 2020ICU Medical, Inc.
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
Open, Classified
FJKK983559
Apr 17, 2020Baxter Healthcare Corporation
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Terminated
FJKK070414
K100364
Apr 17, 2020Baxter Healthcare Corporation
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Terminated
FJKK070414
K100364
Apr 17, 2020Baxter Healthcare Corporation
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Terminated
FJKK070414
K100364
Apr 17, 2020Baxter Healthcare Corporation
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems.
Terminated
FJKK070414
K100364
Dec 19, 2017Nipro Medical Corporation
Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. The Nipro Set - Blood Tubing Set with Transducer Protector and Pri
Terminated
FJKK072024
Jan 8, 2016Nipro Medical Corporation
NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemod
Terminated
FJKK112628
Apr 11, 2014Gambro Renal Products, Incorporated
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gam
Terminated
FJKNone listed
Jan 10, 2011Fresenius Medical Care Holdings, Inc.
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7
Terminated
FJKK962081
Jan 10, 2011Fresenius Medical Care Holdings, Inc.
Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2695-9
Terminated
FJKK962081
Sep 26, 2008Gambro Renal Products, Inc.
Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
Terminated
FJKK070414
Sep 26, 2008Gambro Renal Products, Inc.
Gambro Cartridge Blood Set, 003410-510, is intended for single use in a hemodialysis treatment using the Phoenix and Centry system 3 Dialysis Delivery Systems.
Terminated
FJKK070414
May 7, 2008B. Braun Medical, Inc.
Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210517. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 18
Terminated
FJKK952631
May 7, 2008B. Braun Medical, Inc.
Diapact CRRT Assembled Kit HF/HD with Manifold and Standard Spike, item number 7210513. The product is shipped 4 units per shipping carton. Hemodialysis kit, B. Braun Medical, Inc., Allentown, PA 181
Terminated
FJKK952631

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