510(k) · Cleared
ClearedVIAL-MATE Adaptor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corporation · LHI Set, I.V. Fluid Transfer
Cleared on Nov 19, 2014 as substantially equivalent to K973654 (Baxter Healthcare Corp, 1997) after a 65-day review. Its family tree reaches back 2 generations to 1991. 6 later devices descend from it.
- Decided
- Nov 19, 2014
- Review
- 65 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910793 (1991). 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK910793 Reconstitution DeviceBaxter Healthcare Corp · 1991
- 1 generation backK973654 Vial-Mate Reconstitution Device (2B8071)Baxter Healthcare Corp · 1997 · Recalled
- This deviceK142600 VIAL-MATE AdaptorBaxter Healthcare Corporation · 2014
- Descendant · cites it directly · 5 of its ownK201415 Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK230988 Vial2Bag Advanced® 13mm Admixture DeviceWest Pharma. Services IL, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK252987 ADRx™ Admixture DeviceEpic Medical Pte., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK240940 Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK212525 Advcare Vial Direct to Bag (VDB) Needle-free Admixture DevicesAdvcare Medical · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201415Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc. · 2020 · cites it directly5descendants
- K230988Vial2Bag Advanced® 13mm Admixture DeviceWest Pharma. Services IL, Ltd. · 2023 · 2 generations on1descendant
- K252987ADRx™ Admixture DeviceEpic Medical Pte., Ltd. · 2026 · 2 generations on0descendants
- K240940Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc. · 2024 · 3 generations on0descendants
- K212525Advcare Vial Direct to Bag (VDB) Needle-free Admixture DevicesAdvcare Medical · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910793 | Reconstitution Device | Baxter Healthcare Corp | 1991 | — |
| −1 | K973654 | Vial-Mate Reconstitution Device (2B8071) | Baxter Healthcare Corp | 1997 | 1 |
| 0 (this device) | K142600 | VIAL-MATE Adaptor | Baxter Healthcare Corporation | 2014 | — |
| +1 | K201415 | Vial2Bag Advanced 20mm Admixture Device | West Pharmaceutical Services Az, Inc. | 2020 | 1 |
| +2 | K230988 | Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. | 2023 | — |
| +2 | K252987 | ADRx™ Admixture Device | Epic Medical Pte., Ltd. | 2026 | — |
| +3 | K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | 2024 | — |
| +2 | K212525 | Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices | Advcare Medical | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K973654 | Vial-Mate Reconstitution Device (2B8071)Summary page 6…redicate 510(k)s Device Company Predicate 510(k) Clearance date VIAL-MATE Reconstitution Device Baxter Healthcare K973654 October 24, 1997 DEVICE DESCRIPTION: The VIAL-MATE Reconstitution Device is intended for use by the pharmacist or he… | 1997 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201415 | Vial2Bag Advanced 20mm Admixture Device | 2020 | 5 |
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 23 years and passes through 2 companies; a new generation was cleared every 17.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K201415 (West Pharmaceutical Services Az, Inc., 2020) has gone furthest, with 5 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. 2014, 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?
To provide the pharmacist or health practitioner a means of connecting a standard 20 mm single dose drug vial to an I.V. solution
container without mixing the vial contents with the diluent until immediately before administration of the reconstituted drug to the
patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142600: VIAL-MATE Adaptor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142600
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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