Data / Medical devices / Germany / Fresenius Kabi Deutschland GMBH
Fresenius Kabi Deutschland GMBH: FDA-registered device maker in BAD HERSFELD Hesse, Germany, 5 510(k) clearances
Fresenius Kabi Deutschland GMBH is registered with the FDA (registration 9681819) in BAD HERSFELD Hesse, Germany. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated June 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681819
- FEI number
- 3000147578
- Address
- 5 Robert-Koch-Strasse, BAD HERSFELD Hesse, Germany, D-36251
- Owner or operator
- Fresenius Kabi AG (9027285)
- Roles
- Specification developer
- First device listed
- May 23, 2013
- Registered through
- 2026
- Brand names listed
- K-Zero Needleless Connector, Transfer Set, VOLUMAT LINES, VOLUMAT MC AGILIA, Volumat Line, freeflex+ Transfer Adapter
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Irrigation | GBX | 1 | Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| June 16, 2023 | K221121 | Volumat Polyethylene I.V. Administration Set | FPA | Substantially Equivalent | Fresenius Kabi | accessdata.fda.gov |
| June 2, 2023 | K220301 | Volumat Line | FPA | Substantially Equivalent | Fresenius Kabi | accessdata.fda.gov |
| June 1, 2022 | K212445 | freeflex+ Transfer Adapter | LHI | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
| June 15, 2017 | K162826 | Encore Neutral | FPA | Substantially Equivalent | Rymed Technologies, LLC | accessdata.fda.gov |
| May 1, 2013 | K121613 | AGILIA INFUSION SYSTEM | FRN | Substantially Equivalent | Fresenius Kabi AG | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Set, I.V. Fluid Transfer
- All makers of Pump, Infusion
- All makers of Catheter, Irrigation
Updated June 16, 2023. 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.