# K010103: Surshield Winged Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Mar 15, 2001 after 62 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.
13 later devices descend from it; 2 cite it directly.
0 of 14 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
- K031266: Surshield Safety Winged Infusion Set (2003), 7 descendants of its own
- K052887: Surflo Winged Infusion Set with Needle Protection (Surshield), Model SV-S23BL35VS (2005), 6 descendants of its own
- K070547: Surflo Winged Infusion Set with Filter and Needle Protection (Surshield) (2007), 4 descendants of its own
- K013164: Surshield Safety Winged Blood Collection Set (2001), 4 descendants of its own
- K072894: Surflo Winged Infusion Set with Needle Protection (Surshield) (2007), 3 descendants of its own

Source page: https://510kreport.com/device/K010103
Methodology: https://510kreport.com/methodology