# K052887: Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VS

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: Dec 8, 2005 after 56 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 K010103 (2001). 2 ancestors in all.
6 later devices descend from it; 4 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)
- K031266: Surshield Safety Winged Infusion Set, Terumo Corp. (2003) Summary page 2.

## Most influential descendants
- 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
- K133894: Surflo Winged Infusion Set with Filter & Needle Protection (Surshield) (2014), 0 descendants of its own

## Indications for use
The Surflo Winged Infusion Set with Needle Protection (Surshield) is intended to access the peripheral vascular system, for intravenous administration of fluids and/or withdrawal of blood specimens using a syringe, luer adapter, or other compatible/appropriate devices. 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/K052887
Methodology: https://510kreport.com/methodology