510(k) · Cleared
ClearedEva TPN Bag
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Valmed S.R.L. · KPE Container, I.V.
Cleared on Apr 13, 2011 as substantially equivalent to K041415 (B.Braun Medical, Inc., 2004) and 2 other predicates after a 328-day review. Its family tree reaches back 3 generations to 1994. 8 later devices descend from it.
- Decided
- Apr 13, 2011
- Review
- 328 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K932477 (1994). 4 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK932477 Unimix Conainer-Empty Container W/3 Lead Trans.SetBaxter Healthcare Corp · 1994
- 2 generations backK983294 All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102…Baxter Healthcare Corp · 1998
- 1 generation backK041415 Eva TPN ContainerB.Braun Medical, Inc. · 2004 · Recalled
- This deviceK101412 Eva TPN BagValmed S.R.L. · 2011
- Descendant · cites it directly · 6 of its ownK181393 Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP…Valmed S.R.L. · 2019
- Descendant · 2 generations on · 2 of its ownK223674 eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK201936 SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC · 2021
- Descendant · 3 generations on · 1 of its ownK241442 eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK251980 ClaveQS™ BagIcu Medical, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K181393Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP…Valmed S.R.L. · 2019 · cites it directly6descendants
- K223674eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte., Ltd. · 2023 · 2 generations on2descendants
- K201936SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC · 2021 · 2 generations on2descendants
- K241442eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte., Ltd. · 2024 · 3 generations on1descendant
- K251980ClaveQS™ BagIcu Medical, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932477 | Unimix Conainer-Empty Container W/3 Lead Trans.Set | Baxter Healthcare Corp | 1994 | — |
| −2 | K983294 | All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152… | Baxter Healthcare Corp | 1998 | — |
| −1 | K041415 | Eva TPN Container | B.Braun Medical, Inc. | 2004 | 1 |
| 0 (this device) | K101412 | Eva TPN Bag | Valmed S.R.L. | 2011 | — |
| +1 | K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP… | Valmed S.R.L. | 2019 | — |
| +2 | K223674 | eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) | Epic Medical Pte., Ltd. | 2023 | — |
| +2 | K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | Gilero, LLC | 2021 | — |
| +3 | K241442 | eZSURE™ Empty Fluid Container with ProSeal™ Injection Site | Epic Medical Pte., Ltd. | 2024 | — |
| +3 | K251980 | ClaveQS™ Bag | Icu Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K041415 | Eva TPN ContainerSummary page 1…Hospital (21 CFR §880.5025) 0. Product Code: KPE LEGALLY MARKETED DEVICES (PREDICATE DEVICES) - B. BRAUN MEDICAL INC.: EVA TPN Container, K041415 - BAXTER HEALTHCARE CORPORATION: ALL-IN-ONE CONTAINER, K090096, K983294 Confidential Section 14 S… | 2004 |
| * | K090096 | All-in-One ContainerSummary page 1…LEGALLY MARKETED DEVICES (PREDICATE DEVICES) - B. BRAUN MEDICAL INC.: EVA TPN Container, K041415 - BAXTER HEALTHCARE CORPORATION: ALL-IN-ONE CONTAINER, K090096, K983294 Confidential Section 14 Summary of safety and effectiveness rev 2 Page 14 -2 === Pag… | 2009 |
| * | K983294 | All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112…Summary page 1…D DEVICES (PREDICATE DEVICES) - B. BRAUN MEDICAL INC.: EVA TPN Container, K041415 - BAXTER HEALTHCARE CORPORATION: ALL-IN-ONE CONTAINER, K090096, K983294 Confidential Section 14 Summary of safety and effectiveness rev 2 Page 14 -2 VALMVED s… | 1998 |
What descends from it? (8)
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 17 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K181393 (Valmed S.R.L., 2019) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K041415.
How does its category compare?
All KPE devicesKPE Container, I.V.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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 bag is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101412: Eva TPN Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101412
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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