# K133894: Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: Mar 18, 2014 after 88 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K970259 (1997). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070547: Surflo Winged Infusion Set with Filter and Needle Protection (Surshield), Terumo Europe N.V. (2007) Summary page 3.

## Recalls of this device
- Nov 23, 2015 · Class II · Z-0551-2016: Potential improper bonding between the tube and luer for certain lots of Surflo Winged Infusion Set with Filter and Needle Protection (Surshield).

## Indications for use
The Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) is intended to access the peripheral vascular system, for single-dose or short-term intravenous administration of fluids using a syringe 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/K133894
Methodology: https://510kreport.com/methodology