510(k) · Cleared
Recalled · Class II · 2025IVX Fluid Transfer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnicell, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Apr 24, 2022 as substantially equivalent to K152441 (Kiro Robotics S.L., 2015) after a 256-day review. Its family tree reaches back 6 generations to 1991. It has been recalled once.
- Decided
- Apr 24, 2022
- Review
- 256 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K903493 (1991). 8 ancestors in all, the oldest K894827 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 5 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- 4 generations backK022431 Medrad Transfer SetMedrad, Inc. · 2002
- 3 generations backK040456 Fleboset MultipleLaboratorios Grifols, S.A. · 2004
- 2 generations backK050339 Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005
- 1 generation backK152441 KIRO SetKiro Robotics S.L. · 2015
- This deviceK212530 IVX Fluid Transfer SetOmnicell, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −5 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| −4 | K022431 | Medrad Transfer Set | Medrad, Inc. | 2002 | — |
| −3 | K040456 | Fleboset Multiple | Laboratorios Grifols, S.A. | 2004 | — |
| −2 | K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple | Laboratorios Grifols, S.A. | 2005 | — |
| −1 | K152441 | KIRO Set | Kiro Robotics S.L. | 2015 | — |
| 0 (this device) | K212530 | IVX Fluid Transfer Set | Omnicell, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K152441 | KIRO SetSummary page 4…et Classification Name: 21 CFR 880.5440 Set, I.V. Fluid Transfer Regulatory Class: II Product Code: LHI Secondary Product Code: NEP 510(k) Number: K152441 590 East Middlefield Road, Mountain View, CA 94043 800-850-6664 | 650-251-6100 Omnicell.com 4. Device… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 20, 2025 | Class II | Z-1532-2025 | Process control | IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 6 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K152441.
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 TVX Fluid Transfer Set is a single use device indicated for use with the IVX Station Pharmacy Compounding System.
The TVX Fluid Transfer device contains three separate tubing configurations and is indicated for the following applications:
* Aseptic withdraw of fluid from I.V. bag(s) in preparation for compounding,
* aseptic reconstitution oflyophilized drug in vial(s) from an I.V. bag source and
* aseptic transfer of fluid from an I.V. bag of compounded drug into a final container(s)
for use in the preparation of final compounded drugs for patient infusion administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212530 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212530: IVX Fluid Transfer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212530
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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