510(k) · Cleared
ClearedSet Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube
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 Dec 17, 2003 after a 23-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Dec 17, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK033682 Set Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection TubeLaboratorios Grifols, S.A. · 2003
- 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 · 2 generations on · 1 of its ownK170110 Diana Medication Transfer SetIcu Medical, Inc. · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK212530 IVX Fluid Transfer SetOmnicell, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 0 of its ownK203674 B Dispensing LineAea Srl · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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
- K170110Diana Medication Transfer SetIcu Medical, Inc. · 2018 · 2 generations on1descendant
- K212530IVX Fluid Transfer SetOmnicell, Inc. · 2022 · 3 generations on0descendants
- K203674B Dispensing LineAea Srl · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033682 | Set Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube | Laboratorios Grifols, S.A. | 2003 | — |
| +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 | — |
| +2 | K170110 | Diana Medication Transfer Set | Icu Medical, Inc. | 2018 | 1 |
| +3 | K212530 | IVX Fluid Transfer Set | Omnicell, Inc. | 2022 | 1 |
| +3 | K203674 | B Dispensing Line | Aea Srl | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | — | Exacta-Mix Set Named without a submission number | |
| * | — | Baxter transfer sets presented together with compounder Named without a submission number |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple | 2005 | 6 |
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?
- Of its descendants, K050339 (Laboratorios Grifols, S.A., 2005) has gone furthest, with 6 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?
All models of SETS GRI-FILL 2.0 fluid transfer sets are ancillary devices used in conjunction with the GRI-FILL 2.0 pharmacy compounding device in hospital pharmacy to provide a fluid pathway through which one or more source solutions are delivered into a single Gri-bag or Gri-flex container or into a standard syringe or pump.
The device should not be used with lipids.
It is restricted to sale by or on order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033682 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033682: Set Gri-Fill 2.0-1 Way; 2.0-2 Ways; Luer Connection Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033682
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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