510(k) · Cleared
ClearedFleboset Double
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 Jan 13, 2011 as substantially equivalent to K093182 (Laboratorios Grifols, S.A., 2010) and 1 other predicate after a 126-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Jan 13, 2011
- Review
- 126 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
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 backK082752 QuickpinLaboratorios Grifols, S.A. · 2008
- 1 generation backK093182 Set Gri-Fill 3.0Laboratorios Grifols, S.A. · 2010
- This deviceK102590 Fleboset DoubleLaboratorios Grifols, S.A. · 2011
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 | K082752 | Quickpin | Laboratorios Grifols, S.A. | 2008 | — |
| −1 | K093182 | Set Gri-Fill 3.0 | Laboratorios Grifols, S.A. | 2010 | — |
| 0 (this device) | K102590 | Fleboset Double | Laboratorios Grifols, S.A. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2000 | 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? (2)
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 |
|---|---|---|---|
| * | K093182 | Set Gri-Fill 3.0Summary page 1…E: I.V. FLUID TRANSFER SETS (21 CFR 880.5440) PREDICATE DEVICE(S): SET GRI-FILL 3.0 6-to-I (Laboratodos Grifols - K093182) FLEBOSET MULTIPLE (Laboratorios Grifols - K040456) DEVICE DESCRIPTION:… | 2010 |
| * | K040456 | Fleboset MultipleSummary page 1…SET GRI-FILL 3.0 6-to-I (Laboratodos Grifols - K093182) FLEBOSET MULTIPLE (Laboratorios Grifols - K040456) DEVICE DESCRIPTION: Disposable fluid transfer set for connection to agravity or… | 2004 |
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 20 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
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. 2011, 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?
Disposable transfer set through which substances from 2 different vials containing the same solution may be continuously delivered for: a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to channel the solution from the source vials to the infusion set, and b) Pharmacy Compounding when used in conjunction with the Grifill 3.0 pharmacy compounding device and associated transfer…
Read the full statement (205 words)
Disposable transfer set through which substances from 2 different vials containing the same solution may be continuously delivered for:
a) IV administration when used in conjunction with a gravity or pump infusion set, with luer-lock connection to the drip chamber, to channel the solution from the source vials to the infusion set, and
b) Pharmacy Compounding when used in conjunction with the Grifill 3.0 pharmacy compounding device and associated transfer sets.
Equipped with a spike on each line and a 0.2 jam hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances. Facilitates easy puncture of thick rubber stoppers of small diameter. Provides fast fluid addition and extraction due to the large surface area of the air-filter.
Set tubing is PVC with DEHP plasticizer. Do not use with lipids, suspensions or solutions that are incompatible with PVC with DEHP plasticizer. Substances that are known to show incompatibility include, but are not limited to, Paclitaxel, Docetaxel, Etoposide, Carmustine, Propofol, Nitroglycerin, Isosorbide Dinitrate, Diazepam. For information concerning compatibility of substances, please consult the information provided by the manufacturer.
This device is intended to be used by trained healthcare personnel. It is restricted to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102590 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102590: Fleboset Double.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102590
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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