510(k) · Cleared
Recalled · Class II · 2018Secure Eva Dual Chamber Mixing Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Secure Medical Products, Inc. · KPE Container, I.V.
Cleared on Apr 30, 1996 after a 78-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it. It has been recalled 9 times.
- Decided
- Apr 30, 1996
- Review
- 78 days
- Class
- Class II
- Product code
- KPE
- Recalls
- 9
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK960581 Secure Eva Dual Chamber Mixing BagSecure Medical Products, Inc. · 1996
- 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 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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) | K960581 | Secure Eva Dual Chamber Mixing Bag | Secure Medical Products, Inc. | 1996 | — |
| +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 |
|---|---|---|
| 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041038 | Churchill Medical Dual Chamber Empty Container | 2004 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 21, 2018 | Class II | Z-0001-2020 | Process control | Potential for leaking product |
| Sep 21, 2018 | Class II | Z-0002-2020 | Process control | Potential for leaking product |
| Sep 21, 2018 | Class II | Z-0003-2020 | Process control | Potential for leaking product |
| Sep 21, 2018 | Class II | Z-0004-2020 | Process control | Potential for leaking product |
| Sep 21, 2018 | Class II | Z-0005-2020 | Process control | Potential for leaking product |
| Sep 21, 2018 | Class II | Z-0006-2020 | Process control | Potential for leaking product |
| Sep 21, 2018 | Class II | Z-0007-2020 | Process control | Potential for leaking product |
| Sep 21, 2018 | Class II | Z-0008-2020 | Process control | Potential for leaking product |
| Jun 23, 2016 | Class II | Z-2263-2016 | Device Design | An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the… |
The 5 latest of 9 recalls; the web page lists all.
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/K960581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960581: Secure Eva Dual Chamber Mixing Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960581
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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