510(k) · Cleared

Cleared

Medrad Swabbable Valve Transfer Set

K031808510(k) SpecialCleared Jul 11, 200329-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medrad, Inc. · FPK Tubing, Fluid Delivery

Cleared on Jul 11, 2003 as substantially equivalent to K022431 (Medrad, Inc., 2002) after a 29-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.

Decided: Jul 11, 2003
Review: 29 days
Class: Class II
Product code: FPK
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K903493 (1991). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
2 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
1 generation backK022431 Medrad Transfer SetMedrad, Inc. · 2002
This deviceK031808 Medrad Swabbable Valve Transfer SetMedrad, Inc. · 2003
Descendant · cites it directly · 0 of its ownK102073 Med-RX Transfer Set, Models 10-1227TS, 10-1300TS, 10-1305TS and…Benlan, Inc. · 2010
Descendant · cites it directly · 0 of its ownK063114 Disposable Transfer Sets with and Without Swabbable Valves and/or…Coeur, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all

K102073Med-RX Transfer Set, Models 10-1227TS, 10-1300TS, 10-1305TS and 10-1306TSBenlan, Inc. · 2010 · cites it directly0descendants
K063114Disposable Transfer Sets with and Without Swabbable Valves and/or Check ValvesCoeur, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K903493	Namic Contrast Savings Delivery System	North American Instrument Corp.	1991	—
−2	K961794	Fluid Administration Set - Contrast Manager	Merit Medical Systems, Inc.	1996	—
−1	K022431	Medrad Transfer Set	Medrad, Inc.	2002	—
0 (this device)	K031808	Medrad Swabbable Valve Transfer Set	Medrad, Inc.	2003	—
+1	K102073	Med-RX Transfer Set, Models 10-1227TS, 10-1300TS, 10-1305TS and 10-1306TS	Benlan, Inc.	2010	—
+1	K063114	Disposable Transfer Sets with and Without Swabbable Valves and/or Check Valves	Coeur, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2010	1	0

FIG. 1 — Lineage of K031808, 1991–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K022431	Medrad Transfer Set	Medrad, Inc.	2002	—

Also cleared against K022431: 3 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102073	Med-RX Transfer Set, Models 10-1227TS, 10-1300TS, 10-1305TS and 10-1306TS	Benlan, Inc.	2010	0
K063114	Disposable Transfer Sets with and Without Swabbable Valves and/or Check Valves	Coeur, Inc.	2007	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 12 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K102073 (Benlan, Inc., 2010) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K022431.

How does its category compare?

All FPK devices

FPK Tubing, Fluid Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPK

1in 2013

2007high 1 (2007) · low 0 (2008)2026

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

2007high 14 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FPK

30in 2025

2007high 112 (2011) · low 4 (2020)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 Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031808 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031808: Medrad Swabbable Valve 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/K031808

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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