# K221411: Surflo Winged Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.
- Decided: Jun 23, 2023 after 403 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 K771204 (1977). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771204: Surflo Winged Infusion Set, Terumo America, Inc. (1977) Summary page 5.

## Indications for use
The Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size.

Source page: https://510kreport.com/device/K221411
Methodology: https://510kreport.com/methodology