510(k) · Cleared
ClearedKabiHelp® Uno; KabiHelp® Advance plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Kabi AG · KPE Container, I.V.
Cleared on Jan 9, 2026 as substantially equivalent to K210749 (Haemotronic S.P.A., 2021) after a 270-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jan 9, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945193 (1995). 10 ancestors in all, the oldest K911567 (1991). No later device cites it as a predicate yet.
- Root · 6 generations backK945193 All-in-One Two Chamber ContainerBaxter Healthcare Corp · 1995
- 5 generations backK020485 All-in-One Two Chamber Container 3200 ML, 2000 ML & 1000 MLBaxter Healthcare Corp · 2002
- 4 generations backK041038 Churchill Medical Dual Chamber Empty ContainerChurchill Medical Systems, Inc. · 2004
- 3 generations backK121161 Empty Eva Solution Container Empty Eva Dual Chamber Solution ContainerActa Medical, LLC · 2012
- 2 generations backK193528 Empty EVA BagHaemotronic S.P.A. · 2020
- 1 generation backK210749 Empty EVA BagHaemotronic S.P.A. · 2021
- This deviceK251139 KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945193 | All-in-One Two Chamber Container | Baxter Healthcare Corp | 1995 | — |
| −5 | K020485 | All-in-One Two Chamber Container 3200 ML, 2000 ML & 1000 ML | Baxter Healthcare Corp | 2002 | — |
| −4 | K041038 | Churchill Medical Dual Chamber Empty Container | Churchill Medical Systems, Inc. | 2004 | — |
| −3 | K121161 | Empty Eva Solution Container Empty Eva Dual Chamber Solution Container | Acta Medical, LLC | 2012 | — |
| −2 | K193528 | Empty EVA Bag | Haemotronic S.P.A. | 2020 | — |
| −1 | K210749 | Empty EVA Bag | Haemotronic S.P.A. | 2021 | — |
| 0 (this device) | K251139 | KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPE device
- #1 K223674 eZSURE™ Empty Fluid Container (models 426030…score 13.1 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K210749 | Empty EVA BagSummary page 5…ation Number 880.5025 Product Code KPE Legally Marketed Predicate Device Predicate 510(k) Number K210749 Predicate Trade Name Empty EVA Bag Product Code KPE… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 10 ancestors have a recall of any class.
How does its category compare?
All KPE devicesKPE Container, I.V.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · KPE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPE
183in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPE
16in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · KPE
220in 2025
MAUDE reports naming product code KPE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 43 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 1 | — | 3 | 38 |
| 2010 | 0 | — | 14 | 87 |
| 2011 | 2 | — | 0 | 797 |
| 2012 | 1 | — | 0 | 1,229 |
| 2013 | 1 | — | 0 | 622 |
| 2014 | 0 | — | 2 (2) | 575 |
| 2015 | 0 | — | 0 | 543 |
| 2016 | 0 | — | 0 | 527 |
| 2017 | 0 | — | 1 | 284 |
| 2018 | 0 | — | 13 | 142 |
| 2019 | 3 | 183 | 0 | 205 |
| 2020 | 1 | — | 0 | 147 |
| 2021 | 2 | — | 0 | 162 |
| 2022 | 0 | — | 2 | 112 |
| 2023 | 2 | — | 0 | 127 |
| 2024 | 1 | — | 16 | 158 |
| 2025 | 2 | — | 0 | 220 |
| 2026 | 3 | 270 | 0 | — |
What is it indicated for?
The KabiHelp® Bag is an empty container to be filled with components of parenteral nutrition and parenteral nutrition related medication to be administered to the patients using an intravascular administration set. Parenteral nutrition and parenteral nutrition related medication transfer in and out of the container is done using aseptic technique.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251139 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251139: KabiHelp® Uno; KabiHelp® Advance plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251139
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026