510(k) · Cleared
ClearedMEDRAD Imaging Bulk Package Transfer Spike
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Medical Care, Inc. · PQH Iodinated Contrast Media Transfer Tubing Set
Cleared on Jul 30, 2020 as substantially equivalent to K173913 (Bayer U.S., LLC, 2018) after a 177-day review. Its family tree reaches back 4 generations to 1979. 1 later device descends from it.
- Decided
- Jul 30, 2020
- Review
- 177 days
- Class
- Class II
- Product code
- PQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K791131 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK791131 Flu Ven TR-1Venospital, Inc. · 1979
- 3 generations backK041178 Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004
- 2 generations backK133147 Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014
- 1 generation backK173913 MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 2018
- This deviceK200280 MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK253688 MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253688MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K791131 | Flu Ven TR-1 | Venospital, Inc. | 1979 | — |
| −3 | K041178 | Empower Transfer Set, (Cat. NO. 7725) | E-Z-Em, Inc. | 2004 | — |
| −2 | K133147 | Bracco Injeenering Transfer Set | Bracco Injeneering S.A. | 2014 | — |
| −1 | K173913 | MEDRAD® Imaging Bulk Package Transfer Set | Bayer U.S., LLC | 2018 | — |
| 0 (this device) | K200280 | MEDRAD Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2020 | — |
| +1 | K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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
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 |
|---|---|---|---|
| * | K173913 | MEDRAD® Imaging Bulk Package Transfer SetSummary page 4…MEDRAD® Imaging Bulk Package Transfer Set (IBP Transfer Set) Bayer U.S. LLC K173913, May 04, 2018 Device Description: The MEDRAD® Imaging Bulk Package Transfer Spike (Tran… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | 2026 | 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 41 years and passes through 5 companies; a new generation was cleared every 9.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K253688 (Bayer Medical Care, Inc., 2026) has gone furthest, with 0 descendants of its own.
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. 2020, 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 Spike (Transfer Spike) is indicated for the transfer of Gadavist® (gadobutrol) injection contrast media as supplied in an approved Imaging Bulk package presentation (30 mL or 65mL) to empty, sterile hand syringes and/or empty, sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for MR procedures. The…
Read the full statement (107 words)
The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is indicated for the transfer of Gadavist® (gadobutrol) injection contrast media as supplied in an approved Imaging Bulk package presentation (30 mL or 65mL) to empty, sterile hand syringes and/or empty, sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for MR procedures.
The Transfer Spike is to be discarded after one of the following conditions has occurred first: the contrast media container has been depleted, the Transfer Spike has been disconnected from the contrast vial, or after 24 hours has elapsed since the container was penetrated.
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/K200280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200280: MEDRAD Imaging Bulk Package Transfer Spike.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200280
Report an extraction error
Are you the manufacturer?
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