510(k) · Cleared
ClearedVitalmix Plus Empty I.V. Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pacific Device, Inc. · KPE Container, I.V.
Cleared on Nov 5, 1997 after a 127-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Nov 5, 1997
- Review
- 127 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK972464 Vitalmix Plus Empty I.V. ContainerPacific Device, Inc. · 1997
- 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) | K972464 | Vitalmix Plus Empty I.V. Container | Pacific Device, Inc. | 1997 | — |
| +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), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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)
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 | — |
What is it indicated for?
The VITALMIX PLUS Empty I.V. Container is intended for use in the preparation “of drug admixtures of compatible medications.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972464: Vitalmix Plus Empty I.V. Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972464
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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