# K052252: Contrast Media Transfer Sets

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Nov 16, 2005 after 90 days
- Product code: FPA (Set, Administration, Intravascular)
- 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: 2 generations back to K903493 (1991). 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)
- K955179: Contrast Media Set, B.Braun Medical, Inc. (1997) Summary page 1.
- K903493: Namic Contrast Savings Delivery System, North American Instrument Corp. (1991) Summary page 1.
- K961794: Fluid Administration Set - Contrast Manager, Merit Medical Systems, Inc. (1996) Summary page 1.

## Indications for use
The Contrast Media Transfer Sets are intended to be used for the transfer of contrast media from a primary source container to a secondary unit. These sets are intended to allow for multiple unit doses from the same Contrast Media primary container.

Source page: https://510kreport.com/device/K052252
Methodology: https://510kreport.com/methodology