# K181718: BD FlowSmart Set/MiniMed Pro-Set

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson and Company
- Decided: Oct 18, 2018 after 111 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: 5 generations back to K033290 (2004). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160651: BD FlowSmart Set, MiniMed Pro-Set, Becton, Dickinson and Company (2016) Summary page 4.

## Indications for use
The BD FlowSmart™ Set/MiniMed™ Pro-Set™ set is intended for the subcutaneous infusion of medication, including insulin, from an external infusion pump.

Source page: https://510kreport.com/device/K181718
Methodology: https://510kreport.com/methodology