510(k) Report

510(k) · Cleared

Cleared

Empower Transfer Set, (Cat. NO. 7725)

K041178510(k) TraditionalCleared Jul 16, 200472-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

E-Z-Em, Inc. · FPK Tubing, Fluid Delivery

Cleared on Jul 16, 2004 as substantially equivalent to K791131 (Venospital, Inc., 1979) after a 72-day review. Its family tree reaches back 1 generation to 1979. 7 later devices descend from it.

Decided
Jul 16, 2004
Review
72 days
Class
Class II
Product code
FPK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K791131 (1979). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2007: 1 descendant cleared2016: 1 descendant cleared2018: 1 descendant cleared2020: 2 descendants cleared2026: 1 descendant clearedK791131 · Flu Ven TR-1 · Venospital, Inc. · 197919801990200020102020
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K791131 · Flu Ven TR-1 · Venospital, Inc. · 19790
  1. Root · 1 generation backK791131 Flu Ven TR-1Venospital, Inc. · 1979
  2. This deviceK041178 Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004
  3. Descendant · cites it directly · 5 of its ownK133147 Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014
  4. Descendant · 2 generations on · 2 of its ownK173913 MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 2018
  5. Descendant · 3 generations on · 1 of its ownK200280 MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020
  6. Descendant · 2 generations on · 1 of its ownK161723 ulrich Transfer SetUlrich GmbH & Co. KG · 2016
  7. Descendant · 4 generations on · 0 of its ownK253688 MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2007: 12014: 12016: 12018: 12020: 22026: 1
2007high 2 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 7 · See all
  • K133147Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014 · cites it directly5descendants
  • K173913MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 2018 · 2 generations on2descendants
  • K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020 · 3 generations on1descendant
  • K161723ulrich Transfer SetUlrich GmbH & Co. KG · 2016 · 2 generations on1descendant
  • K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K791131Flu Ven TR-1Venospital, Inc.1979—
0 (this device)K041178Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc.2004—
+1K133147Bracco Injeenering Transfer SetBracco Injeneering S.A.2014—
+2K173913MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC2018—
+3K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.2020—
+2K161723ulrich Transfer SetUlrich GmbH & Co. KG2016—
+4K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201410
201610
201810
202020
202610
FIG. 1 — Lineage of K041178, 1979–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K791131Flu Ven TR-1
Summary page 1
…Product Code: FPK Regulatory Class: II Predicate Device: Venusa Flu Ven Tr-1 (K791131) Indications for Use: The Empower Transfer Set is intended to deliver fluid…
Venospital, Inc.1979—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K133147Bracco Injeenering Transfer SetBracco Injeneering S.A.20145
K063114Disposable Transfer Sets with and Without Swabbable Valves and/or Check ValvesCoeur, Inc.20070

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?

  • Its one ancestor has no recall.
  • Of its descendants, K133147 (Bracco Injeneering S.A., 2014) has gone furthest, with 5 descendants of its own.

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

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?

The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.

Indications for use as stated in the FDA summary.

More from E-Z-Em, Inc.

56 FDA decisions under this applicant name. See the company

  • K071378Modification to Empower CT/Cta Injector System, Models 9800/9900 Product SeriesE-Z-Em, Inc. · 2007
  • K062449Empowermr Injector System, Model 9730E-Z-Em, Inc. · 2007
  • K063029Empower CT/Cta Injector System, Model 9800/9900E-Z-Em, Inc. · 2006
  • K053008E-Z-EM Endoscopic CO2 RegulatorE-Z-Em, Inc. · 2005
  • K031571Empowercta Injector System, Models 9930 & 9910 & 9825E-Z-Em, Inc. · 20033 recalls

Recent decisions in FPK

The FPK category page

  • K131517Medrad Twist & GO High Pressure Connector TubingMedrad, Inc. / Bayer Medical Care, Inc. · 2013
  • K063114Disposable Transfer Sets with and Without Swabbable Valves and/or Check ValvesCoeur, Inc. · 2007
  • 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
  • K031808Medrad Swabbable Valve Transfer SetMedrad, Inc. · 2003

https://510kreport.com/device/K041178 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041178: Empower Transfer Set, (Cat. NO. 7725).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041178

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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