510(k) · Cleared
Recalled · Class II · 2013Vial-Mate Reconstitution Device (2B8071)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · LHI Set, I.V. Fluid Transfer
Cleared on Oct 24, 1997 as substantially equivalent to K910793 (Baxter Healthcare Corp, 1991) after a 29-day review. Its family tree reaches back 1 generation to 1991. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 24, 1997
- Review
- 29 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910793 (1991). 7 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910793 Reconstitution DeviceBaxter Healthcare Corp · 1991
- This deviceK973654 Vial-Mate Reconstitution Device (2B8071)Baxter Healthcare Corp · 1997
- Descendant · cites it directly · 6 of its ownK142600 VIAL-MATE AdaptorBaxter Healthcare Corporation · 2014
- Descendant · 2 generations on · 5 of its ownK201415 Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc. · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK230988 Vial2Bag Advanced® 13mm Admixture DeviceWest Pharma. Services IL, Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK252987 ADRx™ Admixture DeviceEpic Medical Pte., Ltd. · 2026
- Descendant · 4 generations on · 0 of its ownK240940 Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142600VIAL-MATE AdaptorBaxter Healthcare Corporation · 2014 · cites it directly6descendants
- K201415Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc. · 2020 · 2 generations on5descendants
- K230988Vial2Bag Advanced® 13mm Admixture DeviceWest Pharma. Services IL, Ltd. · 2023 · 3 generations on1descendant
- K252987ADRx™ Admixture DeviceEpic Medical Pte., Ltd. · 2026 · 3 generations on0descendants
- K240940Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910793 | Reconstitution Device | Baxter Healthcare Corp | 1991 | — |
| 0 (this device) | K973654 | Vial-Mate Reconstitution Device (2B8071) | Baxter Healthcare Corp | 1997 | — |
| +1 | K142600 | VIAL-MATE Adaptor | Baxter Healthcare Corporation | 2014 | — |
| +2 | K201415 | Vial2Bag Advanced 20mm Admixture Device | West Pharmaceutical Services Az, Inc. | 2020 | 1 |
| +3 | K230988 | Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. | 2023 | — |
| +3 | K252987 | ADRx™ Admixture Device | Epic Medical Pte., Ltd. | 2026 | — |
| +4 | K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K910793 | Reconstitution DeviceSummary page 1…stitution and transfer of drugs into Baxter solution containers. This product is similar to the currently marketed Baxter ReConPlus™ Reconstitution Device, cleared under K910793 on March 21, 1991. Like the ReConPlus™ Reconstitution Device, it provides a means of connecting a standard 20 mm single dose drug… | 1991 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142600 | VIAL-MATE Adaptor | 2014 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2013 | Class II | Z-0392-2014 | Packaging process control | Incomplete foil seal on one lot of sterile product. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K142600 (Baxter Healthcare Corporation, 2014) has gone furthest, with 6 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 proposed Vial-Mate Reconstitution Device has the same intended use as previously cleared devices of its type. The Vial-Mate Reconstitution Device is intended to provide the pharmacist or health practitioner a means of connecting a standard 20 mm single dose drug vial to an LV. solution container without mixing the vial contents with the diluent until immediately before administration of the reconstituted drug to the 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/K973654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973654: Vial-Mate Reconstitution Device (2B8071).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973654
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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