Data / Medical devices / Germany / TST GmbH
TST GmbH: FDA-registered device maker in Gernsheim Hesse, Germany, 12 510(k) clearances
TST GmbH is registered with the FDA (registration 3016096143) in Gernsheim Hesse, Germany. It lists 8 device types. The FDA files 12 510(k) clearances under its listings, the newest dated February 10, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016096143
- Address
- Marie-Curie-Str. 1a, Gernsheim Hesse, Germany, 64579
- Owner or operator
- FRESENIUS MEDICAL CARE (8010838)
- Roles
- Exporter to the US
- First device listed
- March 28, 2017
- Registered through
- 2027
- Brand names listed
- 5008X Hemodialysis System, AquaA, AquaB LITE, AquaBplus, AquaBplus & AquaBplus B2, AquaBplus & AquaBplus B2 & AquaBplus HF, AquaBplus & AquaBplus HF, AquaC UNO H and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | 2 | Exporter to the US | accessdata.fda.gov |
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | Exporter to the US | accessdata.fda.gov |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | 2 | Exporter to the US | accessdata.fda.gov |
| Disinfectant, Dialysate Delivery System | NII | 2 | Exporter to the US | accessdata.fda.gov |
| Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure | QJZ | 2 | Exporter to the US | accessdata.fda.gov |
| Set, Administration, For Peritoneal Dialysis, Disposable | KDJ | 2 | Exporter to the US | accessdata.fda.gov |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | 2 | Exporter to the US | accessdata.fda.gov |
| Subsystem, Water Purification | FIP | 2 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 10, 2026 | K252459 | multiFlux 130 (F00013123); multiFlux 160 (F00013124) | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 30, 2025 | K243505 | 5008X Hemodialysis System | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| June 13, 2024 | K232953 | AquaBplus; AquaB LITE | FIP | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| February 2, 2024 | K231534 | 5008X Hemodialysis System | KDI | Substantially Equivalent | Fresenius Medical Care | accessdata.fda.gov |
| December 1, 2023 | K233159 | pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 11, 2023 | K220721 | FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 | KDI | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| July 27, 2022 | K213507 | AquaA | FIP | Substantially Equivalent | Fresenius Medical Care Rental Therapies Group, LLC | accessdata.fda.gov |
| February 21, 2020 | K191407 | Novalung System | QJZ | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| May 18, 2017 | K162716 | bibag | KPO | Substantially Equivalent | Fresenius Medical Care Renal Therapies Group, LLC | accessdata.fda.gov |
| October 19, 2015 | K143617 | AquaC UNO H | FIP | Substantially Equivalent | Vivonic GmbH | accessdata.fda.gov |
| April 22, 2014 | K133829 | AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF | FIP | Substantially Equivalent | Vivonic GmbH | accessdata.fda.gov |
| December 29, 2008 | K083542 | FRESENIUS STERILE STAY SAFE CAP | KDJ | Substantially Equivalent | Fresenius Medical Care North America | accessdata.fda.gov |
Compare with other makers
- All makers of Subsystem, Water Purification
- All makers of Dialyzer, High Permeability With Or Without Sealed Dialysate System
- All makers of Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
- All makers of Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
- All makers of Disinfectant, Dialysate Delivery System
- All makers of Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Updated February 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.