510(k) · Cleared
ClearedDMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Technoflex Sas. · KPE Container, I.V.
Cleared on Apr 18, 2025 as substantially equivalent to K201936 (Gilero, LLC, 2021) after a 59-day review. Its family tree reaches back 6 generations to 1994.
- Decided
- Apr 18, 2025
- Review
- 59 days
- Class
- Class II
- Product code
- KPE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K932477 (1994). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK932477 Unimix Conainer-Empty Container W/3 Lead Trans.SetBaxter Healthcare Corp · 1994
- 5 generations backK983294 All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102…Baxter Healthcare Corp · 1998
- 4 generations backK041415 Eva TPN ContainerB.Braun Medical, Inc. · 2004 · Recalled
- 3 generations backK101412 Eva TPN BagValmed S.R.L. · 2011
- 2 generations backK181393 Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP…Valmed S.R.L. · 2019
- 1 generation backK201936 SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLGilero, LLC · 2021
- This deviceK250459 DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container…Technoflex Sas. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K932477 | Unimix Conainer-Empty Container W/3 Lead Trans.Set | Baxter Healthcare Corp | 1994 | — |
| −5 | K983294 | All-in-One Container Cat#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152… | Baxter Healthcare Corp | 1998 | — |
| −4 | K041415 | Eva TPN Container | B.Braun Medical, Inc. | 2004 | 1 |
| −3 | 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 | — |
| −1 | K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL | Gilero, LLC | 2021 | — |
| 0 (this device) | K250459 | DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX… | Technoflex Sas. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K201936 | SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mLSummary page 5…Panel: General Hospital 5. Predicate Device Information: Gilero, LLC, SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL, K201936 6. Device Description The subject device DMRX Empty Solution Container are IV bags for hospital use which consist of two… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K201936.
How does its category compare?
All KPE devicesKPE Container, I.V.: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 TECHNOFLEX DMRX Empty solution container is empty container used for administration of
intravenous solutions to the patient using an intravascular administration set.
Medication transfer in and out of the container is done using aseptic technique.
After use the bag is discarded.
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/K250459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250459: DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250459
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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