# K033350: BD Vacutainer Safety-Lok Administration Set with Filter

- Pathway: 510(k) (Special)
- Applicant: Becton, Dickinson & CO
- Decided: Nov 18, 2003 after 29 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 K970259 (1997). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 2.

## Most influential descendants
- K070547: Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) (2007), 4 descendants of its own
- K100946: Intravscular Administration Set (2010), 2 descendants of its own
- K140175: Intravascular Administration Set (2014), 0 descendants of its own
- K133894: Surflo Winged Infusion Set with Filter & Needle Protection (Surshield) (2014), 0 descendants of its own
- K133867: Surflo Winged Infusion Set with Needle Protection (Surshield) (2014), 0 descendants of its own

## Indications for use
The BD Vacutainer Safety-Lok Administration Set with Filter is a sterile, single-use wing set intended for the intravenous administration of fluids and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The BD Vacutainer Safety-Lok Administration Set with Filter minimizes the possibility of needlesticks if manually activated following administration.

Source page: https://510kreport.com/device/K033350
Methodology: https://510kreport.com/methodology