510(k) · Cleared
Recalled · Class II · 2024Vial2Bag Advanced 20mm Admixture Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
West Pharmaceutical Services Az, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Oct 21, 2020 as substantially equivalent to K142600 (Baxter Healthcare Corporation, 2014) after a 145-day review. Its family tree reaches back 3 generations to 1991. 5 later devices descend from it. It has been recalled once.
- Decided
- Oct 21, 2020
- Review
- 145 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K910793 (1991). 5 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK910793 Reconstitution DeviceBaxter Healthcare Corp · 1991
- 2 generations backK973654 Vial-Mate Reconstitution Device (2B8071)Baxter Healthcare Corp · 1997 · Recalled
- 1 generation backK142600 VIAL-MATE AdaptorBaxter Healthcare Corporation · 2014
- This deviceK201415 Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK230988 Vial2Bag Advanced® 13mm Admixture DeviceWest Pharma. Services IL, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK252987 ADRx™ Admixture DeviceEpic Medical Pte., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK240940 Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK212525 Advcare Vial Direct to Bag (VDB) Needle-free Admixture DevicesAdvcare Medical · 2022
- Descendant · cites it directly · 0 of its ownK212445 freeflex+ Transfer AdapterFresenius Kabi AG · 2022
Most influential descendants
Showing 5 of 5 · See all- K230988Vial2Bag Advanced® 13mm Admixture DeviceWest Pharma. Services IL, Ltd. · 2023 · cites it directly1descendant
- K252987ADRx™ Admixture DeviceEpic Medical Pte., Ltd. · 2026 · cites it directly0descendants
- K240940Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc. · 2024 · 2 generations on0descendants
- K212525Advcare Vial Direct to Bag (VDB) Needle-free Admixture DevicesAdvcare Medical · 2022 · cites it directly0descendants
- K212445freeflex+ Transfer AdapterFresenius Kabi AG · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910793 | Reconstitution Device | Baxter Healthcare Corp | 1991 | — |
| −2 | K973654 | Vial-Mate Reconstitution Device (2B8071) | Baxter Healthcare Corp | 1997 | 1 |
| −1 | K142600 | VIAL-MATE Adaptor | Baxter Healthcare Corporation | 2014 | — |
| 0 (this device) | K201415 | Vial2Bag Advanced 20mm Admixture Device | West Pharmaceutical Services Az, Inc. | 2020 | — |
| +1 | K230988 | Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. | 2023 | — |
| +1 | K252987 | ADRx™ Admixture Device | Epic Medical Pte., Ltd. | 2026 | — |
| +2 | K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | 2024 | — |
| +1 | K212525 | Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices | Advcare Medical | 2022 | — |
| +1 | K212445 | freeflex+ Transfer Adapter | Fresenius Kabi AG | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 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 |
|---|---|---|---|
| * | K142600 | VIAL-MATE AdaptorSummary page 5…5 === Vial2Bag AdvancedTM 20mm Admixture Device Traditional 510(k) 5.3 PREDICATE DEVICE VIAL-MATE Reconstitution Device, K142600 5.4 DEVICE DESCRIPTION Device Design The Vial2Bag AdvancedTM 20mm Admixture Device is a single use, fluid trans… | 2014 |
What descends from it? (5)
4 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2024 | Class II | Z-0283-2025 | Environmental control | Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K230988 (West Pharma. Services IL, Ltd., 2023) has gone furthest, with 1 descendant 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. 2020, 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 Vial2Bag Advanced™ 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201415 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201415: Vial2Bag Advanced 20mm Admixture Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201415
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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