# K151250: Smart Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Top Spins, Inc.
- Decided: Jun 7, 2016 after 392 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This product is intended to be used in an MR environment for the Administration of Contrast and Flush for Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA).

Source page: https://510kreport.com/device/K151250
Methodology: https://510kreport.com/methodology