510(k) · Cleared
ClearedQuickpin
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 Sep 29, 2008 as substantially equivalent to K003730 (Baxter Healthcare Corp, 2000) and 1 other predicate after a 10-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- Sep 29, 2008
- Review
- 10 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). 2 later devices descend from it, 1 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 deviceK082752 QuickpinLaboratorios Grifols, S.A. · 2008
- Descendant · cites it directly · 1 of its ownK093182 Set Gri-Fill 3.0Laboratorios Grifols, S.A. · 2010
- Descendant · 2 generations on · 0 of its ownK102590 Fleboset DoubleLaboratorios Grifols, S.A. · 2011
Most influential descendants
Showing 2 of 2 · See allView 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) | K082752 | Quickpin | Laboratorios Grifols, S.A. | 2008 | — |
| +1 | K093182 | Set Gri-Fill 3.0 | Laboratorios Grifols, S.A. | 2010 | — |
| +2 | 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 |
|---|---|---|
| 2010 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K003730 | Chemo-Aide Dispensing PinSummary page 1…oset Multiple Feature ~~~~~~Dispensing Pin K003730 K040456 1. Intended use IClaims QUICKPIN is a Luer-lock The Baxter CHEMO-AIDE FLEBOSET MULTIPLE… | 2000 |
| * | K040456 | Fleboset MultipleSummary page 1…Feature ~~~~~~Dispensing Pin K003730 K040456 1. Intended use IClaims QUICKPIN is a Luer-lock The Baxter CHEMO-AIDE FLEBOSET MULTIPLE… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093182 | Set Gri-Fill 3.0 | 2010 | 1 |
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 17 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, K093182 (Laboratorios Grifols, S.A., 2010) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K003730.
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. 2008, 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?
QUICKPIN is a Luer-lock spike used in manual or automated pharmacy compounding for addition and / or extraction of IV substances, including antineoplastics and substances for chemotherapy, from rubber-stoppered containers including multidose vials. It is equipped with a 0.2 micron hydrophobic air-filter that minimizes the formation of aerosols when preparing and dispensing the substances.
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/K082752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082752: Quickpin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082752
Report an extraction error
Are you the manufacturer?
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