# K200280: MEDRAD Imaging Bulk Package Transfer Spike

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Medical Care, Inc.
- Decided: Jul 30, 2020 after 177 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: 4 generations back to K791131 (1979). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173913: MEDRAD® Imaging Bulk Package Transfer Set, Bayer U.S., LLC (2018) Summary page 4.

## Most influential descendants
- K253688: MEDRAD® Imaging Bulk Package Transfer Spike (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K200280
Methodology: https://510kreport.com/methodology