510(k) Report

510(k) · Cleared

Cleared

Disposable Transfer Sets with and Without Swabbable Valves and/or Check Valves

K063114510(k) AbbreviatedCleared Feb 9, 2007121-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

Coeur, Inc. · FPK Tubing, Fluid Delivery

Cleared on Feb 9, 2007 as substantially equivalent to K031808 (Medrad, Inc., 2003) and 3 other predicates after a 121-day review. Its family tree reaches back 4 generations to 1991.

Decided
Feb 9, 2007
Review
121 days
Class
Class II
Product code
FPK
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K903493 (1991). 6 ancestors in all, the oldest K791131 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2004: 1 other ancestor1979: 1 other ancestorK903493 · Namic Contrast Savings Delivery System · North American Instrument Corp. · 1991K961794 · Fluid Administration Set - Contrast Manager · Merit Medical Systems, Inc. · 1996K022431 · Medrad Transfer Set · Medrad, Inc. · 2002K031808 · Medrad Swabbable Valve Transfer Set · Medrad, Inc. · 20031975198019851990199520002005
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor K031808 · Medrad Swabbable Valve Transfer Set · Medrad, Inc. · 2003K022431 · Medrad Transfer Set · Medrad, Inc. · 2002K961794 · Fluid Administration Set - Contrast Manager · Merit Medical Systems, Inc. · 1996K903493 · Namic Contrast Savings Delivery System · North American Instrument Corp. · 19910
  1. Root · 4 generations backK903493 Namic Contrast Savings Delivery SystemNorth American Instrument Corp. · 1991
  2. 3 generations backK961794 Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc. · 1996
  3. 2 generations backK022431 Medrad Transfer SetMedrad, Inc. · 2002
  4. 1 generation backK031808 Medrad Swabbable Valve Transfer SetMedrad, Inc. · 2003
  5. This deviceK063114 Disposable Transfer Sets with and Without Swabbable Valves and/or…Coeur, Inc. · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K903493Namic Contrast Savings Delivery SystemNorth American Instrument Corp.1991—
−3K961794Fluid Administration Set - Contrast ManagerMerit Medical Systems, Inc.1996—
−2K022431Medrad Transfer SetMedrad, Inc.2002—
−1K031808Medrad Swabbable Valve Transfer SetMedrad, Inc.2003—
0 (this device)K063114Disposable Transfer Sets with and Without Swabbable Valves and/or Check ValvesCoeur, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
200410
FIG. 1 — Lineage of K063114, 1991–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against? (5)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK073597Fill Tube - Coeur
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
*K031808Medrad Swabbable Valve Transfer SetMedrad, Inc.2003—
*K022431Medrad Transfer Set
Summary page 1
…ces to which Substantial Equivalence is claimed: Fill Tube (K8 73597) - Coeur SVTS - Swabable Valve Transfer Set (KO31808) - Medrad Transfer Set (K022431) - Medrad Contrast Management System (K961 794) - Merit Empower Transfer Set (K041 178) -E-Z-EM INC. 4. Dev…
Medrad, Inc.2002—
*K961794Fluid Administration Set - Contrast Manager
Summary page 1
…Fill Tube (K8 73597) - Coeur SVTS - Swabable Valve Transfer Set (KO31808) - Medrad Transfer Set (K022431) - Medrad Contrast Management System (K961 794) - Merit Empower Transfer Set (K041 178) -E-Z-EM INC. 4. Device Description: The Disposable Transfer Sets w…
Merit Medical Systems, Inc.1996—
*K041178Empower Transfer Set, (Cat. NO. 7725)
Summary page 1
…wabable Valve Transfer Set (KO31808) - Medrad Transfer Set (K022431) - Medrad Contrast Management System (K961 794) - Merit Empower Transfer Set (K041 178) -E-Z-EM INC. 4. Device Description: The Disposable Transfer Sets with and without Swabbable Valves and/or Check…
E-Z-Em, Inc.2004—

Also cleared against K031808: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 16 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
  • None of the 6 ancestors has a recall.
  • 1 other device also cites its predicate K031808.

How does its category compare?

All FPK devices

FPK Tubing, Fluid Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FPK

1in 2013

2007: 12013: 1
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

2008: 92012: 142013: 12017: 1
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

2007: 292008: 782009: 922010: 672011: 1122012: 1072013: 292014: 312015: 152016: 122017: 152018: 92019: 102020: 42021: 82022: 72023: 152024: 82025: 30
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—029
20080—978
20090—092
20100—067
20110—0112
20120—14107
20131—129
20140—031
20150—015
20160—012
20170—115
20180—09
20190—010
20200—04
20210—08
20220—07
20230—015
20240—08
20250—030
20260—0—

What is it indicated for?

for use in transferring contrast, saline, or other diagnostic fluids between bulk containers and a syringe

Indications for use as stated in the FDA summary.

Also cleared against K031808

1 other device cites the same predicate.

  • K102073Med-RX Transfer Set, Models 10-1227TS, 10-1300TS, 10-1305TS and 10-1306TSBenlan, Inc. · 2010

More from Coeur, Inc.

14 FDA decisions under this applicant name. See the company

  • K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack…Coeur, Inc. · 2017
  • K161471MR Syringe Dual Pack for Solaris InjectorsCoeur, Inc. · 2016
  • K150902330psi Extension Y-Line with Dual Check ValveCoeur, Inc. · 2015
  • K142745125mL CT SyringeCoeur, Inc. · 2015
  • K140469MR Syringe Dual PackCoeur, Inc. · 2014

Recent decisions in FPK

The FPK category page

  • K131517Medrad Twist & GO High Pressure Connector TubingMedrad, Inc. / Bayer Medical Care, Inc. · 2013
  • K063239Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528, 17527, 17525 & 17526Hospira, Inc. · 20067 recalls
  • K052431Medtronic Minimed Leapfrog II Infusion Set, Models MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic Minimed · 2005
  • K041178Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004
  • K031808Medrad Swabbable Valve Transfer SetMedrad, Inc. · 2003

https://510kreport.com/device/K063114 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063114: Disposable Transfer Sets with and Without Swabbable Valves and/or Check Valves.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063114

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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