FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
KabiHelp® Uno; KabiHelp® Advance plus
K Number: K251139
·
Decision Jan 9, 2026
Classifications
1
FEI Numbers
86
Registration Numbers
86
Same Product Code
116
Applicant Total
12
Review Days
270
Basic Information
- Device Name
- KabiHelp® Uno; KabiHelp® Advance plus
- K Number
- K251139
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5025
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fresenius Kabi AG
- Date Received
- April 14, 2025
- Decision Date
- January 9, 2026
- Product Code
- KPE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KPE | Container, I.V. | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPE), ordered by most recent decision date.
Disposable Infusion Bag for Parenteral Nutrition
FDA 510(k)
FDA Class 2
·General Hospital
ClaveQS Bag
FDA 510(k)
FDA Class 2
·General Hospital
eZSURE Empty Fluid Container
FDA 510(k)
FDA Class 2
·General Hospital
DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
FDA 510(k)
FDA Class 2
·General Hospital
eZSURE Empty Fluid Container with ProSeal Injection Site
FDA 510(k)
FDA Class 2
·General Hospital
eZSURE Empty Fluid Container (models 426030, 426040, 426110)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Fresenius Kabi AG
| K Number | Device Name | ||
|---|---|---|---|
| K212445 | freeflex+ Transfer Adapter | Jun 1, 2022 | Substantially Equivalent |
| K210073 | Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo | Mar 1, 2022 | Substantially Equivalent |
| K210074 | Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable | Mar 1, 2022 | Substantially Equivalent |
| K210075 | Vigilant Software Suite Vigilant Master Med | Mar 1, 2022 | Substantially Equivalent |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion System | Feb 11, 2021 | Substantially Equivalent |
| K200530 | AMICUS Separator System | Sep 11, 2020 | Substantially Equivalent |
| K192150 | AMICUS Separator System | Nov 13, 2019 | Substantially Equivalent |
| K192368 | CATSmart | Sep 27, 2019 | Substantially Equivalent |
| K180831 | CATSmart | Dec 10, 2018 | Substantially Equivalent |
| K160735 | CATSmart | Sep 16, 2016 | Substantially Equivalent |