# K891063: Surflo (R) Winged Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jun 23, 1989 after 114 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
No predicates in its family tree.
3 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K070362: Surflo Winged Infusion Set (2007), 2 descendants of its own
- 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

Source page: https://510kreport.com/device/K891063
Methodology: https://510kreport.com/methodology