# PQH: Iodinated Contrast Media Transfer Tubing Set

- Device class: 2; regulation: 21 CFR 880.5440; FDA's rule: 510(k) required
- FDA decisions: 6
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2016: 1
- 2018: 1
- 2020: 2
- 2026: 1

## Most-cited predicates
- K133147: Bracco Injeenering Transfer Set (2014), cited by 2
- K161723: ulrich Transfer Set (2016), cited by 1
- K173913: MEDRAD® Imaging Bulk Package Transfer Set (2018), cited by 1
- K200280: MEDRAD Imaging Bulk Package Transfer Spike (2020), cited by 1

Source page: https://510kreport.com/product-code/PQH
Data by year (CSV): https://510kreport.com/product-code/PQH.csv