# K253688: MEDRAD® Imaging Bulk Package Transfer Spike

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Medical Care, Inc.
- Decided: Jun 12, 2026 after 203 days
- Product code: PQH (Iodinated Contrast Media Transfer Tubing Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K791131 (1979). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200280: MEDRAD Imaging Bulk Package Transfer Spike, Bayer Medical Care, Inc. (2020) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K253688
Methodology: https://510kreport.com/methodology