510(k) · Cleared
ClearedDual Compartment TPN Bag 3 Liter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stedim, Inc. · KPE Container, I.V.
Cleared on Aug 2, 1991 after a 115-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Aug 2, 1991
- Review
- 115 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK911567 Dual Compartment TPN Bag 3 LiterStedim, Inc. · 1991
- Descendant · cites it directly · 5 of its ownK041038 Churchill Medical Dual Chamber Empty ContainerChurchill Medical Systems, Inc. · 2004
- Descendant · 2 generations on · 3 of its ownK121161 Empty Eva Solution Container Empty Eva Dual Chamber Solution ContainerActa Medical, LLC · 2012
- Descendant · 3 generations on · 2 of its ownK193528 Empty EVA BagHaemotronic S.P.A. · 2020
- Descendant · 4 generations on · 1 of its ownK210749 Empty EVA BagHaemotronic S.P.A. · 2021
- Descendant · 5 generations on · 0 of its ownK251139 KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K041038Churchill Medical Dual Chamber Empty ContainerChurchill Medical Systems, Inc. · 2004 · cites it directly5descendants
- K121161Empty Eva Solution Container Empty Eva Dual Chamber Solution ContainerActa Medical, LLC · 2012 · 2 generations on3descendants
- K193528Empty EVA BagHaemotronic S.P.A. · 2020 · 3 generations on2descendants
- K210749Empty EVA BagHaemotronic S.P.A. · 2021 · 4 generations on1descendant
- K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911567 | Dual Compartment TPN Bag 3 Liter | Stedim, Inc. | 1991 | — |
| +1 | K041038 | Churchill Medical Dual Chamber Empty Container | Churchill Medical Systems, Inc. | 2004 | — |
| +2 | K121161 | Empty Eva Solution Container Empty Eva Dual Chamber Solution Container | Acta Medical, LLC | 2012 | — |
| +3 | K193528 | Empty EVA Bag | Haemotronic S.P.A. | 2020 | — |
| +4 | K210749 | Empty EVA Bag | Haemotronic S.P.A. | 2021 | — |
| +5 | K251139 | KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AG | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K041038 (Churchill Medical Systems, Inc., 2004) has gone furthest, with 5 descendants of its own.
How does its category compare?
All KPE devicesKPE Container, I.V.: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K911567 · printed Nov 5, 2026
Cite this page
510(k) Report. “K911567: Dual Compartment TPN Bag 3 Liter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K911567
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026