510(k) · Cleared
ClearedBracco Injeenering Transfer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bracco Injeneering S.A. · PQH Iodinated Contrast Media Transfer Tubing Set
Cleared on Jun 20, 2014 as substantially equivalent to K041178 (E-Z-Em, Inc., 2004) after a 246-day review. Its family tree reaches back 2 generations to 1979. 5 later devices descend from it.
- Decided
- Jun 20, 2014
- Review
- 246 days
- Class
- Class II
- Product code
- PQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K791131 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK791131 Flu Ven TR-1Venospital, Inc. · 1979
- 1 generation backK041178 Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004
- This deviceK133147 Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014
- Descendant · cites it directly · 2 of its ownK173913 MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 2018
- Descendant · 2 generations on · 1 of its ownK200280 MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK161723 ulrich Transfer SetUlrich GmbH & Co. KG · 2016
- Descendant · 3 generations on · 0 of its ownK253688 MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK193010 Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC · 2020
Most influential descendants
Showing 5 of 5 · See all- K173913MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 2018 · cites it directly2descendants
- K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020 · 2 generations on1descendant
- K161723ulrich Transfer SetUlrich GmbH & Co. KG · 2016 · cites it directly1descendant
- K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2026 · 3 generations on0descendants
- K193010Liebel-Flarsheim IBP Transfer SetLiebel-Flarsheim Company, LLC · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K791131 | Flu Ven TR-1 | Venospital, Inc. | 1979 | — |
| −1 | K041178 | Empower Transfer Set, (Cat. NO. 7725) | E-Z-Em, Inc. | 2004 | — |
| 0 (this device) | K133147 | Bracco Injeenering Transfer Set | Bracco Injeneering S.A. | 2014 | — |
| +1 | K173913 | MEDRAD® Imaging Bulk Package Transfer Set | Bayer U.S., LLC | 2018 | — |
| +2 | K200280 | MEDRAD Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2020 | — |
| +1 | K161723 | ulrich Transfer Set | Ulrich GmbH & Co. KG | 2016 | — |
| +3 | K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2026 | — |
| +2 | K193010 | Liebel-Flarsheim IBP Transfer Set | Liebel-Flarsheim Company, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2026 | 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 PQH? 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 PQH device
- #1 K253688 MEDRAD® Imaging Bulk Package Transfer Spikescore 12.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K041178 | Empower Transfer Set, (Cat. NO. 7725)Summary page 5…cular Administration Set Intravascular Administration Set 21 CFR §880.5440 FPK BINJ Model Predicate 510(k) Predicate Manufacturer Number and Model BINJ Transfer Set K041178 E-Z-EM, Inc. (now ACIST Medical Systems, Inc.) Empower Transfer Set The Bracco Injeneering (BINJ) Transfer Set is a sterile tub… | 2004 |
What descends from it? (5)
2 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 35 years and passes through 3 companies; a new generation was cleared every 24.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K173913 (Bayer U.S., LLC, 2018) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K041178.
How does its category compare?
All PQH devicesPQH Iodinated Contrast Media Transfer Tubing Set: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · PQH
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PQH
Too few PQH 510(k)s in any year since 2007 to give a median.
Recalls per year · PQH
No recall names PQH since 2007.
Adverse event reports per year · PQH
1in 2021
MAUDE reports naming product code PQH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Bracco Injeneering Transfer Set is a component of a contrast management system and is indicated for the transfer of Isovue {lopamido! Injection) contrast media as supplied in an Imaging Bulk Package to empty sterile syringes on single-use only syringe-based contrast injection systems indicated for the controlled, aulomatic administration on the venous side, of contrast agents for CT procedures. The Transfer Set is to be discarded aficr the contrast media container has been depleted or 10 hours has elapsed since the container was penetrated, whichever occurs first. )
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133147: Bracco Injeenering 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/K133147
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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