510(k) · Cleared
ClearedMIX2VIAL Transfer Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimop Medical Projects, Ltd. · LHI Set, I.V. Fluid Transfer
Cleared on Jul 29, 2003 after a 43-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Jul 29, 2003
- Review
- 43 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK031861 MIX2VIAL Transfer DeviceMedimop Medical Projects, Ltd. · 2003
- Descendant · cites it directly · 4 of its ownK062482 Vented Vial Adapter Transfer DeviceMedimop Medical Projects, Ltd. · 2006
- Descendant · cites it directly · 2 of its ownK183187 nextaro Transfer System, nextaro vaSfm Medical Devices GmbH · 2019
- Descendant · 2 generations on · 2 of its ownK160503 Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK241976 nextaro® va, 15mm, 5µmSfm Medical Devices GmbH · 2024
- Descendant · 2 generations on · 0 of its ownK240748 nextaro® v, 20/20Sfm Medical Devices GmbH · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K062482Vented Vial Adapter Transfer DeviceMedimop Medical Projects, Ltd. · 2006 · cites it directly4descendants
- K183187nextaro Transfer System, nextaro vaSfm Medical Devices GmbH · 2019 · cites it directly2descendants
- K160503Vented Vial Adapter Transfer Device - 13mmMedimop Medical Projects, Ltd. · 2016 · 2 generations on2descendants
- K241976nextaro® va, 15mm, 5µmSfm Medical Devices GmbH · 2024 · 2 generations on0descendants
- K240748nextaro® v, 20/20Sfm Medical Devices GmbH · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031861 | MIX2VIAL Transfer Device | Medimop Medical Projects, Ltd. | 2003 | — |
| +1 | K062482 | Vented Vial Adapter Transfer Device | Medimop Medical Projects, Ltd. | 2006 | — |
| +1 | K183187 | nextaro Transfer System, nextaro va | Sfm Medical Devices GmbH | 2019 | — |
| +2 | K160503 | Vented Vial Adapter Transfer Device - 13mm | Medimop Medical Projects, Ltd. | 2016 | — |
| +2 | K241976 | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH | 2024 | — |
| +2 | K240748 | nextaro® v, 20/20 | Sfm Medical Devices GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LHI? 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 LHI device
- #1 K252987 ADRx™ Admixture Devicescore 12.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
3 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?
- Of its descendants, K062482 (Medimop Medical Projects, Ltd., 2006) has gone furthest, with 4 descendants of its own.
How does its category compare?
All LHI devicesLHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHI
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHI
1in 2024
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · LHI
1,334in 2025
MAUDE reports naming product code LHI, 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 | 3 | 89 | 1 | 18 |
| 2008 | 4 | 154 | 3 | 27 |
| 2009 | 8 | 95 | 1 | 37 |
| 2010 | 5 | 139 | 3 | 49 |
| 2011 | 3 | 99 | 12 | 155 |
| 2012 | 5 | 127 | 0 | 529 |
| 2013 | 4 | 102 | 3 | 154 |
| 2014 | 6 | 63 | 0 | 155 |
| 2015 | 3 | 99 | 0 | 128 |
| 2016 | 3 | 159 | 1 (1) | 219 |
| 2017 | 5 | 56 | 1 | 536 |
| 2018 | 1 | — | 3 (3) | 1,499 |
| 2019 | 4 | 247 | 1 | 1,634 |
| 2020 | 3 | 189 | 0 | 1,171 |
| 2021 | 3 | 396 | 0 | 933 |
| 2022 | 6 | 278 | 2 | 1,834 |
| 2023 | 5 | 90 | 2 (2) | 1,047 |
| 2024 | 9 | 166 | 1 | 1,270 |
| 2025 | 6 | 196 | 0 | 1,334 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Mix2vial Transfer Device is intended for transferring and mixing
drugs contained in two vials.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031861: MIX2VIAL Transfer Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031861
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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