510(k) · Cleared
Clearedfreeflex+ Transfer Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fresenius Kabi AG · LHI Set, I.V. Fluid Transfer
Cleared on Jun 1, 2022 as substantially equivalent to K201415 (West Pharmaceutical Services Az, Inc., 2020) after a 300-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jun 1, 2022
- Review
- 300 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 deviceK212445 freeflex+ Transfer AdapterFresenius Kabi AG · 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) | K212445 | freeflex+ Transfer Adapter | Fresenius Kabi AG | 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 5…Page 2 of 9 Regulatory Class: II Product Code: LHI 510(k) Number: K201415 4. Device Description The freeflex®+ Transfer Adapter is a single use, fluid transfer device that allows for the reconstitution… | 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?
The freeflex@+ Transfer Adapter is indicated for reconstituting and/or admixing a drug in a vial with a 20mm closure and the transfer of the drug into the freeflex@+ IV Bag prior to administration to the patient. The device may be used for pediatric (newborn to 21 years) and adult populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212445: freeflex+ Transfer Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212445
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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