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)
Top companies in FJK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Fresenius 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 |
FJK | K213992 |
| Apr 15, 2026 | B Braun Medical Inc B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705. Open, Classified |
FJK | K080807 |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number: B3-3632M3705. Open, Classified |
FJK | K080807 |
| Apr 15, 2026 | B Braun Medical Inc B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number: SL-2000M2095L. Open, Classified |
FJK | K080807 |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number: SL-2000M2095DA. Open, Classified |
FJK | K080807 |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number: SL-2010M2096 Open, Classified |
FJK | K080807 |
| Apr 15, 2026 | B Braun Medical Inc B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR.
Model Number: SL-2010M2096A. Open, Classified |
FJK | K080807 |
| Oct 22, 2025 | B 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 |
FJK | K080807 |
| Sep 19, 2024 | B 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 |
FJK | K080807 |
| Sep 19, 2024 | B 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 |
FJK | K080807 |
| Sep 19, 2024 | B 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 |
FJK | K080807 |
| Sep 19, 2024 | B 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 |
FJK | K080807 |
| Sep 19, 2024 | B 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 |
FJK | K080807 |
| Sep 19, 2024 | B 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 |
FJK | K080807 |
| Sep 19, 2024 | B 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 |
FJK | K080807 |
| Apr 14, 2021 | Baxter 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 |
FJK | K070414 |
| Dec 30, 2020 | Baxter 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 |
FJK | K100364 |
| Dec 30, 2020 | Baxter 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 |
FJK | K070414 |
| Dec 30, 2020 | Baxter 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 |
FJK | K070414 |
| Dec 30, 2020 | Baxter 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 |
FJK | K070414 |
| Dec 30, 2020 | Baxter 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 |
FJK | K070414 |
| Dec 30, 2020 | Baxter 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 |
FJK | K070414 |
| Aug 31, 2020 | ICU Medical, Inc. 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795 Open, Classified |
FJK | K983559 |
| Apr 17, 2020 | Baxter 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 |
FJK | K070414 K100364 |
| Apr 17, 2020 | Baxter 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 |
FJK | K070414 K100364 |
| Apr 17, 2020 | Baxter 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 |
FJK | K070414 K100364 |
| Apr 17, 2020 | Baxter Healthcare Corporation Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dialysis Delivery Systems. Terminated |
FJK | K070414 K100364 |
| Dec 19, 2017 | Nipro 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 |
FJK | K072024 |
| Jan 8, 2016 | Nipro 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 |
FJK | K112628 |
| Apr 11, 2014 | Gambro 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 |
FJK | None listed |
| Jan 10, 2011 | Fresenius Medical Care Holdings, Inc. Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7 Terminated |
FJK | K962081 |
| Jan 10, 2011 | Fresenius Medical Care Holdings, Inc. Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set
P/N: 03-2695-9 Terminated |
FJK | K962081 |
| Sep 26, 2008 | Gambro 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 |
FJK | K070414 |
| Sep 26, 2008 | Gambro 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 |
FJK | K070414 |
| May 7, 2008 | B. 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 |
FJK | K952631 |
| May 7, 2008 | B. 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 |
FJK | K952631 |
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