# K013164: Surshield Safety Winged Blood Collection Set

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Oct 15, 2001 after 24 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: 2 generations back to K970259 (1997). 5 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010103: Surshield Winged Infusion Set, Terumo Medical Corp. (2001) Summary page 1.
- K983490: Terumo Venoject,Luer Adapter, Terumo Corp. (1998) Summary page 1.
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 2.

## Most influential descendants
- K031279: Surshield Safety Winged Blood Collection Set (2003), 3 descendants of its own
- K192681: Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) (2020), 0 descendants of its own
- K151991: Safelock Disposable Blood Collection Set, Disposable Blood Collection Set (2015), 0 descendants of its own
- K043328: Microflo-Safe Scalp Vein Set (2005), 0 descendants of its own

## Indications for use
The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is a winged blood collection needle intended for venipuncture to collect blood specimens from patients. The TERUMO® SURSHIELD™ SAFETY WINGED BLOOD COLLECTION SET is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient’s vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Source page: https://510kreport.com/device/K013164
Methodology: https://510kreport.com/methodology