510(k) · Cleared
ClearedAdvcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advcare Medical · LHI Set, I.V. Fluid Transfer
Cleared on Aug 19, 2022 as substantially equivalent to K201415 (West Pharmaceutical Services Az, Inc., 2020) after a 373-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Aug 19, 2022
- Review
- 373 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K910793 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK910793 Reconstitution DeviceBaxter Healthcare Corp · 1991
- 3 generations backK973654 Vial-Mate Reconstitution Device (2B8071)Baxter Healthcare Corp · 1997 · Recalled
- 2 generations backK142600 VIAL-MATE AdaptorBaxter Healthcare Corporation · 2014
- 1 generation backK201415 Vial2Bag Advanced 20mm Admixture DeviceWest Pharmaceutical Services Az, Inc. · 2020 · Recalled
- This deviceK212525 Advcare Vial Direct to Bag (VDB) Needle-free Admixture DevicesAdvcare Medical · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K910793 | Reconstitution Device | Baxter Healthcare Corp | 1991 | — |
| −3 | K973654 | Vial-Mate Reconstitution Device (2B8071) | Baxter Healthcare Corp | 1997 | 1 |
| −2 | K142600 | VIAL-MATE Adaptor | Baxter Healthcare Corporation | 2014 | — |
| −1 | K201415 | Vial2Bag Advanced 20mm Admixture Device | West Pharmaceutical Services Az, Inc. | 2020 | 1 |
| 0 (this device) | K212525 | Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices | Advcare Medical | 2022 | — |
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 |
|---|---|---|---|
| * | K201415 | Vial2Bag Advanced 20mm Admixture DeviceSummary page 4…21 CFR 880.5440 Product Code: LHI Device Class: 2 Predicate Device: K201415 Vial2Bag-Advanced Device Indications For Use: Advcare Vial Direct to Bag (VDB) Needle-free Admixture devices are intended for d… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K201415.
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. 2022, 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?
Advcare Vial Direct to Bag (VDB) Needle-free Admixture devices are intended for drug reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution and attaching an IV set to administer infusion liquid to patient. The devices are provided as single-use, sterile, and non-pyrogenic products. The VDB-13 & 20 has an integrated vial adaptor that is used to reconstitute and admix drugs from a drug vial into the solution IV bag. The devices are intended for use in healthcare environments by clinically trained healthcare professional providers to aid and support prescribed treatment and therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212525: Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212525
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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