# K150059: BD FlowSmart Set

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson Company
- Decided: Apr 28, 2015 after 105 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 K033290 (2004). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011071: Paradigm Quick-Set Infusion Set, Maersk Medical A/S (2001) Summary page 4.
- K130468: Orbit Infusion Set, Ypsomed AG (2013) Summary page 4.

## Most influential descendants
- K153257: BD FlowSmart Set, MiniMed Pro-Set (2015), 2 descendants of its own
- K160651: BD FlowSmart Set, MiniMed Pro-Set (2016), 1 descendant of its own
- K181718: BD FlowSmart Set/MiniMed Pro-Set (2018), 0 descendants of its own

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

Source page: https://510kreport.com/device/K150059
Methodology: https://510kreport.com/methodology