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 Jun 12, 2026 as substantially equivalent to K200280 (Bayer Medical Care, Inc., 2020) after a 203-day review. Its family tree reaches back 5 generations to 1979.
- Decided
- Jun 12, 2026
- Review
- 203 days
- Class
- Class II
- Product code
- PQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K791131 (1979). No later device cites it as a predicate yet.
- Root · 5 generations backK791131 Flu Ven TR-1Venospital, Inc. · 1979
- 4 generations backK041178 Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004
- 3 generations backK133147 Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014
- 2 generations backK173913 MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 2018
- 1 generation backK200280 MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020
- This deviceK253688 MEDRAD® Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K791131 | Flu Ven TR-1 | Venospital, Inc. | 1979 | — |
| −4 | K041178 | Empower Transfer Set, (Cat. NO. 7725) | E-Z-Em, Inc. | 2004 | — |
| −3 | K133147 | Bracco Injeenering Transfer Set | Bracco Injeneering S.A. | 2014 | — |
| −2 | 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 | — |
| 0 (this device) | K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2026 | — |
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 K200280 MEDRAD Imaging Bulk Package Transfer Spikescore 3.7 · 4 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 |
|---|---|---|---|
| * | K200280 | MEDRAD Imaging Bulk Package Transfer SpikeSummary page 5…Class II Product Code: PQH III. PREDICATE DEVICE Name of Device: MEDRAD® Imaging Bulk Package Transfer Spike, K200280 Common Name: Contrast Media Transfer Set Classification Name: Intravascular Administratio… | 2020 |
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 47 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- None of the 5 ancestors has a recall.
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. 2026, 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 (IBP) Transfer Spike is indicated for the transfer of the following contrast media: • Ambelvist® (gadoquatrane) injection in IBP • Gadavist® (gadobutrol) injection in IBP The Transfer Spike is used to transfer contrast media to empty, sterile hand syringes for MR procedures. Discard the Transfer Spike after one of the following conditions has occurred first: (1) the Transfer Spike has been disconnected from the contrast…
Read the full statement (115 words)
The MEDRAD® Imaging Bulk Package (IBP) Transfer Spike is indicated for the transfer of the following contrast media:
• Ambelvist® (gadoquatrane) injection in IBP
• Gadavist® (gadobutrol) injection in IBP
The Transfer Spike is used to transfer contrast media to empty, sterile hand syringes for MR procedures.
Discard the Transfer Spike after one of the following conditions has occurred first: (1) the Transfer Spike has been disconnected from the contrast media container; (2) the contrast media container has been depleted; or (3) after contrast media use time has elapsed since the container was penetrated.
For a specific contrast media use time, refer to the contrast media prescribing information or the contrast media IBP container label.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253688: 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/K253688
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026