# K141285: Busse Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Busse Hospital Disposables
- Decided: Feb 19, 2015 after 279 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: 3 generations back to K960280 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103562: Centurion Pressure Injectable Extension Set, Centurion Medical Products Corporation (2011) Summary page 5.

## Indications for use
Busse Extension Sets are intended to be used with a vascular access device for administrative and withdrawals of fluids.

Source page: https://510kreport.com/device/K141285
Methodology: https://510kreport.com/methodology