# K223101: BD Secondary Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Care Fusion
- Decided: May 12, 2023 after 224 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 K991932 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051499: Intravascular Administration Set and Extension Set, Medegen Medical Manufacturing Services (2005) Summary page 4.

## Indications for use
The BD Secondary Set is indicated for continuous or intermittent delivery of IV fluids, medications, including lipids, through intravascular routes of administration. The BD Secondary Set may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

Source page: https://510kreport.com/device/K223101
Methodology: https://510kreport.com/methodology