510(k) · Cleared
ClearedFleboset Multiple
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laboratorios Grifols, S.A. · LHI Set, I.V. Fluid Transfer
Cleared on Mar 9, 2004 as substantially equivalent to K894827 (Baxter Healthcare Corp, 1989) and 2 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1991. 11 later devices descend from it.
- Decided
- Mar 9, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K903493 (1991). 4 ancestors in all, the oldest K894827 (1989). 11 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 2 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- 1 generation backK022431 Medrad Transfer SetMedrad, Inc. · 2002
- This deviceK040456 Fleboset MultipleLaboratorios Grifols, S.A. · 2004
- Descendant · cites it directly · 6 of its ownK050339 Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005
- Descendant · 2 generations on · 3 of its ownK152441 KIRO SetKiro Robotics S.L. · 2015
- Descendant · cites it directly · 2 of its ownK082752 QuickpinLaboratorios Grifols, S.A. · 2008
- Descendant · 2 generations on · 1 of its ownK170110 Diana Medication Transfer SetIcu Medical, Inc. · 2018 · Recalled
- Descendant · cites it directly · 1 of its ownK093182 Set Gri-Fill 3.0Laboratorios Grifols, S.A. · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K050339Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005 · cites it directly6descendants
- K152441KIRO SetKiro Robotics S.L. · 2015 · 2 generations on3descendants
- K082752QuickpinLaboratorios Grifols, S.A. · 2008 · cites it directly2descendants
- K170110Diana Medication Transfer SetIcu Medical, Inc. · 2018 · 2 generations on1descendant
- K093182Set Gri-Fill 3.0Laboratorios Grifols, S.A. · 2010 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −2 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| −1 | K022431 | Medrad Transfer Set | Medrad, Inc. | 2002 | — |
| 0 (this device) | K040456 | Fleboset Multiple | Laboratorios Grifols, S.A. | 2004 | — |
| +1 | K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple | Laboratorios Grifols, S.A. | 2005 | — |
| +2 | K152441 | KIRO Set | Kiro Robotics S.L. | 2015 | — |
| +1 | K082752 | Quickpin | Laboratorios Grifols, S.A. | 2008 | — |
| +2 | K170110 | Diana Medication Transfer Set | Icu Medical, Inc. | 2018 | 1 |
| +1 | K093182 | Set Gri-Fill 3.0 | Laboratorios Grifols, S.A. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K894827 | Automix 3+3 CompounderSummary page 2…ures of both predicate and new devices. Feature Characteristic / FLEBOSET MULTIPLE PREDICATES BAXTER Automix 3+3 (transfer set presented together with compounder) K894827 MEDRAD Transfer Set K022431 MERIT MEDICAL Transfer Sets K961794 1. |intended use/ Cleims FLEBOSET MULTIPLE is an ancillary de… | 1989 |
| * | K022431 | Medrad Transfer SetSummary page 2…w devices. Feature Characteristic / FLEBOSET MULTIPLE PREDICATES BAXTER Automix 3+3 (transfer set presented together with compounder) K894827 MEDRAD Transfer Set K022431 MERIT MEDICAL Transfer Sets K961794 1. |intended use/ Cleims FLEBOSET MULTIPLE is an ancillary device used as fluid pathway th… | 2002 |
| * | K961794 | Fluid Administration Set - Contrast ManagerSummary page 2…FLEBOSET MULTIPLE PREDICATES BAXTER Automix 3+3 (transfer set presented together with compounder) K894827 MEDRAD Transfer Set K022431 MERIT MEDICAL Transfer Sets K961794 1. |intended use/ Cleims FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass s… | 1996 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K050339 (Laboratorios Grifols, S.A., 2005) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K894827.
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?
FLEBOSET MULTIPLE is an ancillary device used as fluid pathway through which substances from 6 glass source flasks containing the same solution may be continuously delivered for:
(a) Pharmacy compounding, when used in conjunction with the GRI-FILL 2.0 pharmacy compounding device and associated transfer sets, and
(b) I.V. administration, when used in conjunction with a gravity or pump infusion set to channel the solution from the source containers to the infusion set.
The device should not be used with lipids.
This device is intended to be used by trained health-care personnel. It is restricted to sale by or on order of a physician.
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/K040456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040456: Fleboset Multiple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040456
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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