510(k) · Cleared
Clearednextaro Transfer System, nextaro va
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sfm Medical Devices GmbH · LHI Set, I.V. Fluid Transfer
Cleared on Mar 15, 2019 as substantially equivalent to K031861 (Medimop Medical Projects, Ltd., 2003) after a 116-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Mar 15, 2019
- Review
- 116 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031861 (2003). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK031861 MIX2VIAL Transfer DeviceMedimop Medical Projects, Ltd. · 2003
- This deviceK183187 nextaro Transfer System, nextaro vaSfm Medical Devices GmbH · 2019
- Descendant · cites it directly · 0 of its ownK241976 nextaro® va, 15mm, 5µmSfm Medical Devices GmbH · 2024
- Descendant · cites it directly · 0 of its ownK240748 nextaro® v, 20/20Sfm Medical Devices GmbH · 2024
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 |
|---|---|---|---|---|---|
| −1 | K031861 | MIX2VIAL Transfer Device | Medimop Medical Projects, Ltd. | 2003 | — |
| 0 (this device) | K183187 | nextaro Transfer System, nextaro va | Sfm Medical Devices GmbH | 2019 | — |
| +1 | K241976 | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH | 2024 | — |
| +1 | K240748 | nextaro® v, 20/20 | Sfm Medical Devices GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K031861 | MIX2VIAL Transfer DeviceSummary page 4…Intravascular Administration Set Regulation Number: 21 CFR 880.5440 Legally Marketed Predicate: Mix2Vial® Transfer Device (K031861) West Pharmaceutical Services, Inc. Reason for Submission: New… | 2003 |
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?
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. 2019, this device’s year, is highlighted.
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 nextaro® Transfer System and nextaro® va is indicated for the transfer and mixing of drugs contained in vials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183187: nextaro Transfer System, nextaro va.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183187
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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