510(k) · Cleared
Recalled · Class II · 2022Eva TPN Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · KPE Container, I.V.
Cleared on Aug 4, 2004 as substantially equivalent to K983294 (Baxter Healthcare Corp, 1998) after a 69-day review. Its family tree reaches back 2 generations to 1994. 10 later devices descend from it. It has been recalled once.
- Decided
- Aug 4, 2004
- Review
- 69 days
- Class
- Class II
- Product code
- KPE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932477 (1994). 10 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK932477 Unimix Conainer-Empty Container W/3 Lead Trans.SetBaxter Healthcare Corp · 1994
- 1 generation backK983294 All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102…Baxter Healthcare Corp · 1998
- This deviceK041415 Eva TPN ContainerB.Braun Medical, Inc. · 2004
- Descendant · cites it directly · 8 of its ownK101412 Eva TPN BagValmed S.R.L. · 2011
- Descendant · 2 generations on · 6 of its ownK181393 Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP…Valmed S.R.L. · 2019
- Descendant · 3 generations on · 2 of its ownK223674 eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte., Ltd. · 2023
- Descendant · 3 generations on · 2 of its ownK201936 SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC · 2021
- Descendant · 4 generations on · 1 of its ownK241442 eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte., Ltd. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K101412Eva TPN BagValmed S.R.L. · 2011 · cites it directly8descendants
- K181393Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP…Valmed S.R.L. · 2019 · 2 generations on6descendants
- K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte., Ltd. · 2023 · 3 generations on2descendants
- K201936SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC · 2021 · 3 generations on2descendants
- K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte., Ltd. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932477 | Unimix Conainer-Empty Container W/3 Lead Trans.Set | Baxter Healthcare Corp | 1994 | — |
| −1 | K983294 | All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152… | Baxter Healthcare Corp | 1998 | — |
| 0 (this device) | K041415 | Eva TPN Container | B.Braun Medical, Inc. | 2004 | — |
| +1 | K101412 | Eva TPN Bag | Valmed S.R.L. | 2011 | — |
| +2 | K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP… | Valmed S.R.L. | 2019 | — |
| +3 | K223674 | eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) | Epic Medical Pte., Ltd. | 2023 | — |
| +3 | K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | Gilero, LLC | 2021 | — |
| +4 | K241442 | eZSURE™ Empty Fluid Container with ProSeal™ Injection Site | Epic Medical Pte., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K983294 | All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112…Summary page 1…N Container COMMON OR USUAL NAME: TPN Bag DEVICE CLASSIFICATION: L.V. Container, 21 CFR Part 880.5025, Product Code KPE PREDICATE DEVICE: K983294 Baxter Healthcare Corporation; All-in-One Container DESCRIPTION: The EVA TPN container is… | 1998 |
What descends from it? (10)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 25, 2022 | Class II | Z-1592-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K101412 (Valmed S.R.L., 2011) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K983294.
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 EVA TPN container is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The EVA TPN container can be filled either by gravity or in conjunction with automated compounding equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041415: Eva TPN Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041415
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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