510(k) · Cleared
ClearedeZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epic Medical Pte., Ltd. · KPE Container, I.V.
Cleared on Sep 1, 2023 as substantially equivalent to K181393 (Valmed S.R.L., 2019) after a 268-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Sep 1, 2023
- Review
- 268 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K932477 (1994). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK932477 Unimix Conainer-Empty Container W/3 Lead Trans.SetBaxter Healthcare Corp · 1994
- 4 generations backK983294 All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102…Baxter Healthcare Corp · 1998
- 3 generations backK041415 Eva TPN ContainerB.Braun Medical, Inc. · 2004 · Recalled
- 2 generations backK101412 Eva TPN BagValmed S.R.L. · 2011
- 1 generation backK181393 Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP…Valmed S.R.L. · 2019
- This deviceK223674 eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)Epic Medical Pte., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK241442 eZSURE™ Empty Fluid Container with ProSeal™ Injection SiteEpic Medical Pte., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK252094 eZSURE™ Empty Fluid ContainerEpic Medical Pte., Ltd. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932477 | Unimix Conainer-Empty Container W/3 Lead Trans.Set | Baxter Healthcare Corp | 1994 | — |
| −4 | K983294 | All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152… | Baxter Healthcare Corp | 1998 | — |
| −3 | K041415 | Eva TPN Container | B.Braun Medical, Inc. | 2004 | 1 |
| −2 | 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 | — |
| 0 (this device) | K223674 | eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) | Epic Medical Pte., Ltd. | 2023 | — |
| +1 | K241442 | eZSURE™ Empty Fluid Container with ProSeal™ Injection Site | Epic Medical Pte., Ltd. | 2024 | — |
| +1 | K252094 | eZSURE™ Empty Fluid Container | Epic Medical Pte., Ltd. | 2025 | — |
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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 K251980 ClaveQS™ Bagscore 12.5 · 6 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 |
|---|---|---|---|
| * | K181393 | Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP…Summary page 4…Code: KPE Regulation Number: 21 CFR 880.5025 Device Class: Class: II III. Predicate Device 510(k) Number: K181393 Empty EVA Bag (models FVM0134BP, FVM0135BP, Proprietary/Trade Name: FVM0136BP, FVM0137BP, FVM… | 2019 |
What descends from it? (2)
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 29 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K241442 (Epic Medical Pte., Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K181393.
How does its category compare?
All KPE devicesKPE Container, I.V.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223674 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223674: eZSURE™ Empty Fluid Container (models 426030, 426040, 426110).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223674
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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