Submission Details
| 510(k) Number | K251139 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 14, 2025 |
| Decision Date | January 09, 2026 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
KabiHelp? Uno; KabiHelp? Advance plus
Jan 2026
Decision
270d
Days
Class 2
Risk
About This 510(k) Submission
K251139 is an FDA 510(k) clearance for the KabiHelp? Uno; KabiHelp? Advance plus, a Container, I.v. (Class II — Special Controls, product code KPE), submitted by Fresenius Kabi AG (Bad Homburg, DE). The FDA issued a Cleared decision on January 9, 2026, 270 days after receiving the submission on April 14, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5025.
Device Classification
| Product Code | KPE — Container, I.v. |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 880.5025 |
Manufacturer
Similar Devices — KPE Container, I.v.
All 114
K252094 · Epic Medical Pte. , Ltd.
· Aug 2025
K250459 · Technoflex Sas.
· Apr 2025
K241442 · Epic Medical Pte. , Ltd.
· Jun 2024
K223674 · Epic Medical Pte. , Ltd.
· Sep 2023
K222622 · Beijing L&Z Medical Technology Development Co., Ltd.
· Feb 2023
K210749 · Haemotronic S.P.A.
· Aug 2021
More from Fresenius Kabi AG
View all
K212445
· LHI · Jun 2022
K210073
· FRN · Mar 2022
K210074
· FRN · Mar 2022
K210075
· PHC · Mar 2022
K210089
· CAC · Feb 2021