# K070547: Surflo Winged Infusion Set with Filter and Needle Protection (Surshield)

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: May 25, 2007 after 88 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 K970259 (1997). 6 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033350: BD Vacutainer Safety-Lok Administration Set with Filter, Becton, Dickinson & CO (2003) Summary page 2.
- K052887: Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VS, Terumo Europe N.V. (2005) Summary page 2.

## Most influential descendants
- 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 Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is intended to access the peripheral vascular system for intravenous administration of fluids using a syringe, or other compatible/appropriate devices and may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. Additionally, after withdrawal of the needle from the patient's vein, the shield cover can be manually activated to cover the needle to minimize risk of accidental needle stick.

Source page: https://510kreport.com/device/K070547
Methodology: https://510kreport.com/methodology