510(k) · Cleared
ClearedAll-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · KPE Container, I.V.
Cleared on Nov 3, 1998 as substantially equivalent to K932477 (Baxter Healthcare Corp, 1994) after a 43-day review. Its family tree reaches back 1 generation to 1994. 12 later devices descend from it.
- Decided
- Nov 3, 1998
- Review
- 43 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932477 (1994). 12 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK932477 Unimix Conainer-Empty Container W/3 Lead Trans.SetBaxter Healthcare Corp · 1994
- This deviceK983294 All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102…Baxter Healthcare Corp · 1998
- Descendant · cites it directly · 10 of its ownK041415 Eva TPN ContainerB.Braun Medical, Inc. · 2004 · Recalled
- Descendant · cites it directly · 9 of its ownK090096 All-in-One ContainerBaxter Healthcare Corporation · 2009
- 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
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K041415Eva TPN ContainerB.Braun Medical, Inc. · 2004 · cites it directly10descendants
- K090096All-in-One ContainerBaxter Healthcare Corporation · 2009 · cites it directly9descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932477 | Unimix Conainer-Empty Container W/3 Lead Trans.Set | Baxter Healthcare Corp | 1994 | — |
| 0 (this device) | 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 |
| +1 | K090096 | All-in-One Container | Baxter Healthcare Corporation | 2009 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K932477 | Unimix Conainer-Empty Container W/3 Lead Trans.SetSummary page 1…ing from 150 mL to 4000 mL. The proposed container is similar to Baxter Healthcare Corporation’s currently marketed All-In-One ™ Container cleared on June 10, 1994 under K932477. There is one solutior: contact material in the proposed All-In-One™ Container which is new to Baxter. It is an ethy ene vinyl a… | 1994 |
What descends from it? (12)
See all 123 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?
- Its one ancestor has no recall.
- Of its descendants, K041415 (B.Braun Medical, Inc., 2004) has gone furthest, with 10 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 All-In-One™ Container is intended for use in the compounding and storage of parenteral
nutrition solutions prior to and during intravascular administration to a patient.
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/K983294 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983294: All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983294
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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