Fresenius Medical Care Renal Therapies Group, LLC
FDA 510(k) & PMA Approved Devices — 48 products
Total Devices48
Categories10
Latest FDA decision2026-07-24
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | KPO | 2023-12-01 | View |
| 510(k) | K213992 | CombiSet Hemodialysis Blood Tubing Set | FJK | 2023-05-31 | View |
| 510(k) | K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 | KDI | 2023-05-11 | View |
| 510(k) | K220281 | multiFiltratePRO System | KDI | 2022-12-16 | View |
| 510(k) | K222318 | Fresenius Liberty Select Cycler | FKX | 2022-10-31 | View |
| 510(k) | K222952 | 2008T BlueStar Hemodailysis Machine | KDI | 2022-10-27 | View |
| 510(k) | K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | 2022-05-12 | View |
| 510(k) | K212522 | Lilliput APD System | FKX | 2022-04-15 | View |
| 510(k) | K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR | KDI | 2020-12-28 | View |
| 510(k) | K192707 | Optiflux F180NR Dialyzer | KDI | 2020-09-21 | View |
| 510(k) | K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line | KOC | 2020-09-18 | View |
| 510(k) | K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | KPO | 2020-05-08 | View |
| 510(k) | K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | KPO | 2020-04-24 | View |
| 510(k) | K191474 | NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) | KPO | 2020-02-24 | View |
| 510(k) | K191407 | Novalung System | QJZ | 2020-02-21 | View |
| 510(k) | K190459 | Hemoflow F3 and F4 Dialyzers | FJI | 2019-08-23 | View |
| 510(k) | K182367 | DIASAFEplusUS | FIP | 2019-01-10 | View |
| 510(k) | K181108 | Fresenius Liberty Select Cycler | FKX | 2018-05-24 | View |
| 510(k) | K173593 | stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch | KDJ | 2018-05-21 | View |
| 510(k) | K173972 | 2008T BlueStar Hemodialysis Machine | KDI | 2018-05-10 | View |
No matching devices.
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