Volumat Line
FDA 510(k) K220301 · Fresenius Kabi
510(k) numberK220301
Submission
- Device name
- Volumat Line
- Applicant
- Fresenius Kabi
Bad Hersfeld, DE - Received
- February 2, 2022
- Decision date
- June 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
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More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251139 | KabiHelp® Uno; KabiHelp® Advance plusKPE · Traditional | 01/09/2026SE |
| K221121 | Volumat Polyethylene I.V. Administration SetFPA · Traditional | 06/16/2023SE |
| K212445 | freeflex+ Transfer AdapterLHI · Traditional | 06/01/2022SE |
| K210075 | Vigilant Software Suite Vigilant Master MedPHC · Traditional | 03/01/2022SE |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo…FRN · Traditional | 03/01/2022SE |
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration…FRN · Traditional | 03/01/2022SE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | 02/11/2021SE |
| K200530 | AMICUS Separator SystemGKT · Traditional | 09/11/2020SE |
| K192150 | AMICUS Separator SystemLKN · Traditional | 11/13/2019SE |
| K192368 | CATSmartCAC · Special | 09/27/2019SE |
Questions and answers
When was Volumat Line cleared by the FDA?
Volumat Line (K220301) received a 510(k) decision of Substantially Equivalent on June 2, 2023, 485 days after the submission was received.
What is the product code of K220301?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.