510(k) · Cleared
ClearedSet Gri-Fill 3.0
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 27, 2010 as substantially equivalent to K082752 (Laboratorios Grifols, S.A., 2008) and 1 other predicate after a 111-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it.
- Decided
- Jan 27, 2010
- Review
- 111 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K903493 (1991). 7 ancestors in all, the oldest K894827 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 4 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- 3 generations backK022431 Medrad Transfer SetMedrad, Inc. · 2002
- 2 generations backK040456 Fleboset MultipleLaboratorios Grifols, S.A. · 2004
- 1 generation backK082752 QuickpinLaboratorios Grifols, S.A. · 2008
- This deviceK093182 Set Gri-Fill 3.0Laboratorios Grifols, S.A. · 2010
- Descendant · cites it directly · 0 of its ownK102590 Fleboset DoubleLaboratorios Grifols, S.A. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102590Fleboset DoubleLaboratorios Grifols, S.A. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −4 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| −3 | K022431 | Medrad Transfer Set | Medrad, Inc. | 2002 | — |
| −2 | K040456 | Fleboset Multiple | Laboratorios Grifols, S.A. | 2004 | — |
| −1 | K082752 | Quickpin | Laboratorios Grifols, S.A. | 2008 | — |
| 0 (this device) | K093182 | Set Gri-Fill 3.0 | Laboratorios Grifols, S.A. | 2010 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K082752 | QuickpinSummary page 1…RANSFER SETS CLASSIFICATION NAME: I.V. FLUID TRANSFER SETS (21 CFR 880.5440) PREDICATE DEVICE(S): QUICKPIN (Laboratorios Grifols - K082752) FLEBOSET MULTIPLE (Laboratorios Grifols _K040456) DEVICE DESCRIPTION:… | 2008 |
| * | K040456 | Fleboset MultipleSummary page 1…5440) PREDICATE DEVICE(S): QUICKPIN (Laboratorios Grifols - K082752) FLEBOSET MULTIPLE (Laboratorios Grifols _K040456) DEVICE DESCRIPTION: Fluid transfer set consisting of PVC tubing linking 6 mini-… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102590 | Fleboset Double | 2011 | 0 |
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 19 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K102590 (Laboratorios Grifols, S.A., 2011) has gone furthest, with 0 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. 2010, 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?
SET GRI-FILL 3.0 6 TO 1 is an ancillary device used as a fluid pathway in conjunction with the Gri-fill 3.0 Pharmacy Compounder and associated 1 way or 2 way transfer sets through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. Equipped with a spike on each line and a 0.2 micron hydrophobic air-filter, it minimizes the formation of aerosols when preparing / dispensing the source substances.…
Read the full statement (183 words)
SET GRI-FILL 3.0 6 TO 1 is an ancillary device used as a fluid pathway in conjunction with the Gri-fill 3.0 Pharmacy Compounder and associated 1 way or 2 way transfer sets through which the same substance from up to 6 rubber-stoppered glass vials may be delivered into a final IV container. Equipped with a spike on each line and a 0.2 micron 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.
This device should not be used 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 and Diazepam. For information concerning compatibility of substances, please consult the information provided with the substance.
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/K093182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093182: Set Gri-Fill 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093182
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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