# K160651: BD FlowSmart Set, MiniMed Pro-Set

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson and Company
- Decided: Apr 7, 2016 after 30 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K033290 (2004). 5 ancestors in all.
1 later device descends 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)
- K153257: BD FlowSmart Set, MiniMed Pro-Set, Becton, Dickinson and Company (2015) Summary page 4.

## Most influential descendants
- K181718: BD FlowSmart Set/MiniMed Pro-Set (2018), 0 descendants of its own

## Recalls of this device
- Sep 10, 2017 · Class II · Z-0111-2018: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
- Dec 23, 2016 · Class II · Z-1897-2017: Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.

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

Source page: https://510kreport.com/device/K160651
Methodology: https://510kreport.com/methodology