510(k) · Cleared
ClearedMEDRAD® Imaging Bulk Package Transfer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer U.S., LLC · PQH Iodinated Contrast Media Transfer Tubing Set
Cleared on May 4, 2018 as substantially equivalent to K133147 (Bracco Injeneering S.A., 2014) after a 133-day review. Its family tree reaches back 3 generations to 1979. 2 later devices descend from it.
- Decided
- May 4, 2018
- Review
- 133 days
- Class
- Class II
- Product code
- PQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K791131 (1979). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK791131 Flu Ven TR-1Venospital, Inc. · 1979
- 2 generations backK041178 Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004
- 1 generation backK133147 Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014
- This deviceK173913 MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 2018
- Descendant · cites it directly · 1 of its ownK200280 MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK253688 MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K791131 | Flu Ven TR-1 | Venospital, Inc. | 1979 | — |
| −2 | K041178 | Empower Transfer Set, (Cat. NO. 7725) | E-Z-Em, Inc. | 2004 | — |
| −1 | K133147 | Bracco Injeenering Transfer Set | Bracco Injeneering S.A. | 2014 | — |
| 0 (this device) | K173913 | MEDRAD® Imaging Bulk Package Transfer Set | Bayer U.S., LLC | 2018 | — |
| +1 | K200280 | MEDRAD Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2020 | — |
| +2 | K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 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 |
|---|---|---|---|
| * | K133147 | Bracco Injeenering Transfer SetSummary page 4…Class II Predicate Device: Bracco Injeneering Transfer Set Bracco Injeneering S.A. K133147, June 20, 2014 Device Description: The MEDRAD® Imaging Bulk Package Transfer Set is a p… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200280 | MEDRAD Imaging Bulk Package Transfer Spike | 2020 | 1 |
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 39 years and passes through 4 companies; a new generation was cleared every 9.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K200280 (Bayer Medical Care, Inc., 2020) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K133147.
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. 2018, 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 MEDRAD® Imaging Bulk Package Transfer Set (IBP Transfer Set) is indicated for the transfer of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), and OMNIPAQUE™ (Iohexal) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation to empty sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for CT procedures. The Transfer Set is to be discarded after one of the following conditions has occurred first; the contrast media container has been depleted, the contrast media use time has expired, or 10 hours has elapsed since the container was penetrated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173913: MEDRAD® Imaging Bulk Package 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/K173913
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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