# K031266: Surshield Safety Winged Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: May 30, 2003 after 39 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: 1 generation back to K010103 (2001). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010103: Surshield Winged Infusion Set, Terumo Medical Corp. (2001)

## Most influential descendants
- K052887: Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VS (2005), 6 descendants of its own
- K070547: Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) (2007), 4 descendants of its own
- K072894: Surflo Winged Infusion Set with Needle Protection (Surshield) (2007), 3 descendants of its own
- K100946: Intravscular Administration Set (2010), 2 descendants of its own
- K140175: Intravascular Administration Set (2014), 0 descendants of its own

## Indications for use
The Surshield Safety Winged Infusion Set is intended for intravenous administration of fluids andor withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. The winged infusion set may be used for any patient population with consideration given to patient size. 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 needlestick.

Source page: https://510kreport.com/device/K031266
Methodology: https://510kreport.com/methodology