510(k) · Cleared
ClearedSet Gri-Fill 3.0-1 Way, 2 Ways, 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 Feb 25, 2005 as substantially equivalent to K033682 (Laboratorios Grifols, S.A., 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 4 generations to 1991. 6 later devices descend from it.
- Decided
- Feb 25, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K903493 (1991). 6 ancestors in all, the oldest K894827 (1989). 6 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 3 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- 2 generations backK022431 Medrad Transfer SetMedrad, Inc. · 2002
- 1 generation backK040456 Fleboset MultipleLaboratorios Grifols, S.A. · 2004
- This deviceK050339 Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005
- Descendant · cites it directly · 3 of its ownK152441 KIRO SetKiro Robotics S.L. · 2015
- Descendant · cites it directly · 1 of its ownK170110 Diana Medication Transfer SetIcu Medical, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK212530 IVX Fluid Transfer SetOmnicell, Inc. · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK203674 B Dispensing LineAea Srl · 2021
- Descendant · 2 generations on · 0 of its ownK190157 Diana ChemoClave Transfer SetIcu Medical · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K152441KIRO SetKiro Robotics S.L. · 2015 · cites it directly3descendants
- K170110Diana Medication Transfer SetIcu Medical, Inc. · 2018 · cites it directly1descendant
- K212530IVX Fluid Transfer SetOmnicell, Inc. · 2022 · 2 generations on0descendants
- K203674B Dispensing LineAea Srl · 2021 · 2 generations on0descendants
- K190157Diana ChemoClave Transfer SetIcu Medical · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −3 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| −2 | K022431 | Medrad Transfer Set | Medrad, Inc. | 2002 | — |
| −1 | K040456 | Fleboset Multiple | Laboratorios Grifols, S.A. | 2004 | — |
| 0 (this device) | 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 | — |
| +1 | K170110 | Diana Medication Transfer Set | Icu Medical, Inc. | 2018 | 1 |
| +2 | K212530 | IVX Fluid Transfer Set | Omnicell, Inc. | 2022 | 1 |
| +2 | K203674 | B Dispensing Line | Aea Srl | 2021 | — |
| +2 | K190157 | Diana ChemoClave Transfer Set | Icu Medical | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K033682 | Set Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection TubeSummary page 1…TRANSFER SETS CLASSIFICATION NAME: I.V. FLUID TRANSFER SETS (21 CFR 880.5440) PREDICATE DEVICE: SETS GRI-FILL 2.0 1WAY/I2WAY / LUER (K033682) FLEBOSET MULTIPLE (K040456) DEVICE DESCRIPTION: SETS GRI-FILL 3.0 are fluid transfer… | 2003 |
| * | K040456 | Fleboset MultipleSummary page 1…ANSFER SETS (21 CFR 880.5440) PREDICATE DEVICE: SETS GRI-FILL 2.0 1WAY/I2WAY / LUER (K033682) FLEBOSET MULTIPLE (K040456) DEVICE DESCRIPTION: SETS GRI-FILL 3.0 are fluid transfer sets for use with the GRI-FILL 3.0 pharmacy compounding de… | 2004 |
What descends from it? (6)
2 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 14 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K152441 (Kiro Robotics S.L., 2015) has gone furthest, with 3 descendants of its own.
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?
SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are ancillary devices used in conjunction with the GRI-FILL 3.0 pharmacy compounder in the hospital pharmacy to provide a fluid pathway through which one or two source substances are delivered into a final IV container or syringe. SETS GRI-FILL 3.0 MULTIPLE fluid transfer sets are ancillary devices used as fluid pathways in conjunction with the GRI-FILL 3.0 pharmacy compounder and associated I WAY or…
Read the full statement (130 words)
SETS GRI-FILL 3.0 1 WAY and 2 WAY fluid transfer sets are ancillary devices used in conjunction with the GRI-FILL 3.0 pharmacy compounder in the hospital pharmacy to provide a fluid pathway through which one or two source substances are delivered into a final IV container or syringe.
SETS GRI-FILL 3.0 MULTIPLE fluid transfer sets are ancillary devices used as fluid pathways in conjunction with the GRI-FILL 3.0 pharmacy compounder and associated I WAY or 2 WAY transfer sets through which the same substance from up to 6 source containers may be delivered into a final IV container.
This 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 the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050339 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050339: Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050339
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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