510(k) · Cleared
ClearedMedrad Transfer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · FPK Tubing, Fluid Delivery
Cleared on Sep 5, 2002 as substantially equivalent to K961794 (Merit Medical Systems, Inc., 1996) after a 42-day review. Its family tree reaches back 2 generations to 1991. 15 later devices descend from it.
- Decided
- Sep 5, 2002
- Review
- 42 days
- Class
- Class II
- Product code
- FPK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K903493 (1991). 15 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
- 1 generation backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
- This deviceK022431 Medrad Transfer SetMedrad, Inc. · 2002
- Descendant · cites it directly · 11 of its ownK040456 Fleboset MultipleLaboratorios Grifols, S.A. · 2004
- Descendant · 2 generations on · 6 of its ownK050339 Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005
- Descendant · 3 generations on · 3 of its ownK152441 KIRO SetKiro Robotics S.L. · 2015
- Descendant · 2 generations on · 2 of its ownK082752 QuickpinLaboratorios Grifols, S.A. · 2008
- Descendant · cites it directly · 2 of its ownK031808 Medrad Swabbable Valve Transfer SetMedrad, Inc. · 2003
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K040456Fleboset MultipleLaboratorios Grifols, S.A. · 2004 · cites it directly11descendants
- K050339Set Gri-Fill 3.0-1 Way, 2 Ways, MultipleLaboratorios Grifols, S.A. · 2005 · 2 generations on6descendants
- K152441KIRO SetKiro Robotics S.L. · 2015 · 3 generations on3descendants
- K082752QuickpinLaboratorios Grifols, S.A. · 2008 · 2 generations on2descendants
- K031808Medrad Swabbable Valve Transfer SetMedrad, Inc. · 2003 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K903493 | Namic Contrast Savings Delivery System | North American Instrument Corp. | 1991 | — |
| −1 | K961794 | Fluid Administration Set - Contrast Manager | Merit Medical Systems, Inc. | 1996 | — |
| 0 (this device) | K022431 | Medrad Transfer Set | Medrad, Inc. | 2002 | — |
| +1 | K040456 | Fleboset Multiple | Laboratorios Grifols, S.A. | 2004 | — |
| +2 | K050339 | Set Gri-Fill 3.0-1 Way, 2 Ways, Multiple | Laboratorios Grifols, S.A. | 2005 | — |
| +3 | K152441 | KIRO Set | Kiro Robotics S.L. | 2015 | — |
| +2 | K082752 | Quickpin | Laboratorios Grifols, S.A. | 2008 | — |
| +1 | K031808 | Medrad Swabbable Valve Transfer Set | Medrad, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 FPK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K961794 | Fluid Administration Set - Contrast ManagerSummary page 1…travascular Administration Set Classification: 80 FPK, Class II Predicate Device: Merit Contrast Management System (K961794) Device Description - The Medrad Transfer Set is medical disposable device used to transfer intravascular contrast media and sal… | 1996 |
What descends from it? (15)
See all 154 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 11 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K040456 (Laboratorios Grifols, S.A., 2004) has gone furthest, with 11 descendants of its own.
- 5 other devices also cite its predicate K961794.
How does its category compare?
All FPK devicesFPK Tubing, Fluid Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FPK
Too few FPK 510(k)s in any year since 2007 to give a median.
Recalls per year · FPK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPK
30in 2025
MAUDE reports naming product code FPK, 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 | 1 | — | 0 | 29 |
| 2008 | 0 | — | 9 | 78 |
| 2009 | 0 | — | 0 | 92 |
| 2010 | 0 | — | 0 | 67 |
| 2011 | 0 | — | 0 | 112 |
| 2012 | 0 | — | 14 | 107 |
| 2013 | 1 | — | 1 | 29 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 1 | 15 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 30 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022431: Medrad Transfer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022431
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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