# K070362: Surflo Winged Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: May 7, 2007 after 89 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 K891063 (1989). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891063: Surflo (R) Winged Infusion Set, Terumo Medical Corp. (1989) Summary page 1.

## Most influential descendants
- K152323: Disposable Infusion Needle, Safelock Disposable Infusion Needle (2015), 1 descendant of its own
- K221078: Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use (2022), 0 descendants of its own

## Indications for use
The Surflo Winged Infusion Set 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.

Source page: https://510kreport.com/device/K070362
Methodology: https://510kreport.com/methodology