510(k) · Cleared
ClearedChurchill Medical Dual Chamber Empty Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Churchill Medical Systems, Inc. · KPE Container, I.V.
Cleared on Dec 21, 2004 as substantially equivalent to K960581 (Secure Medical Products, Inc., 1996) and 3 other predicates after a 243-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Dec 21, 2004
- Review
- 243 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K945193 (1995). 5 ancestors in all, the oldest K911567 (1991). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK945193 All-in-One Two Chamber ContainerBaxter Healthcare Corp · 1995
- 1 generation backK020485 All-in-One Two Chamber Container 3200 ML, 2000 ML & 1000 MLBaxter Healthcare Corp · 2002
- This deviceK041038 Churchill Medical Dual Chamber Empty ContainerChurchill Medical Systems, Inc. · 2004
- Descendant · cites it directly · 3 of its ownK121161 Empty Eva Solution Container Empty Eva Dual Chamber Solution ContainerActa Medical, LLC · 2012
- Descendant · 2 generations on · 2 of its ownK193528 Empty EVA BagHaemotronic S.P.A. · 2020
- Descendant · 3 generations on · 1 of its ownK210749 Empty EVA BagHaemotronic S.P.A. · 2021
- Descendant · 4 generations on · 0 of its ownK251139 KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG · 2026
- Descendant · cites it directly · 0 of its ownK073538 Dual Chamber TPN ContainerB.Braun Medical, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K121161Empty Eva Solution Container Empty Eva Dual Chamber Solution ContainerActa Medical, LLC · 2012 · cites it directly3descendants
- K193528Empty EVA BagHaemotronic S.P.A. · 2020 · 2 generations on2descendants
- K210749Empty EVA BagHaemotronic S.P.A. · 2021 · 3 generations on1descendant
- K251139KabiHelp® Uno; KabiHelp® Advance plusFresenius Kabi AG · 2026 · 4 generations on0descendants
- K073538Dual Chamber TPN ContainerB.Braun Medical, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945193 | All-in-One Two Chamber Container | Baxter Healthcare Corp | 1995 | — |
| −1 | K020485 | All-in-One Two Chamber Container 3200 ML, 2000 ML & 1000 ML | Baxter Healthcare Corp | 2002 | — |
| 0 (this device) | K041038 | Churchill Medical Dual Chamber Empty Container | Churchill Medical Systems, Inc. | 2004 | — |
| +1 | 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 | — |
| +3 | K210749 | Empty EVA Bag | Haemotronic S.P.A. | 2021 | — |
| +4 | K251139 | KabiHelp® Uno; KabiHelp® Advance plus | Fresenius Kabi AG | 2026 | — |
| +1 | K073538 | Dual Chamber TPN Container | B.Braun Medical, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 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? (4)
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 |
|---|---|---|---|
| * | K960581 | Secure Eva Dual Chamber Mixing BagSummary page 1…Class II C.F.R. 880.5025 Product code: KPE FDA registration number: 1223004 Predicate Devices: 510(k) Name Manufacturer K960581 Dual Chamber Empty Container Secure Medical Products K911567 Dual Chamber Empty Container Stedi… | 1996 |
| * | K911567 | Dual Compartment TPN Bag 3 LiterSummary page 1…04 Predicate Devices: 510(k) Name Manufacturer K960581 Dual Chamber Empty Container Secure Medical Products K911567 Dual Chamber Empty Container Stedim Inc. K020485 Two Chamber Container Baxter Healthcare… | 1991 |
| * | K020485 | All-in-One Two Chamber Container 3200 ML, 2000 ML & 1000 MLSummary page 1…Manufacturer K960581 Dual Chamber Empty Container Secure Medical Products K911567 Dual Chamber Empty Container Stedim Inc. K020485 Two Chamber Container Baxter Healthcare Corp. K972464 Vitamix Container1 Pacif… | 2002 |
| * | K972464 | Vitalmix Plus Empty I.V. ContainerSummary page 1…Secure Medical Products K911567 Dual Chamber Empty Container Stedim Inc. K020485 Two Chamber Container Baxter Healthcare Corp. K972464 Vitamix Container1 Pacific Device Device Description: The Churchill Medical Systems Dual Chamber Emp… | 1997 |
What descends from it? (5)
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?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K121161 (Acta Medical, LLC, 2012) has gone furthest, with 3 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?
Churchill Medical Dual Chamber Empty Container is intended for the compounding, storage, and administration of total parenteral nutrition ( TPN solutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041038 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041038: Churchill Medical Dual Chamber Empty Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041038
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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