# K023917: Winged Needle Sets with an Antineedle Stick Protector

- Pathway: 510(k) (Traditional)
- Applicant: Kawasumi Laboratories, Inc.
- Decided: Feb 26, 2003 after 93 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Becton Dickinson Vacutainer Brand Safety-Lok Blood Collection Set: named in the summary without a submission number
- (no number) Kawasumi Winged Collection Set w/ Multi-Sample Luer Adapter: named in the summary without a submission number
- (no number) Kawasumi Small Vein Infusion Set: named in the summary without a submission number

## Most influential descendants
- K102890: K-Shield Small Vein Infusion / Winged Collection Set W/ Anti Needle Stick Protector (and Multisample Luer Adapter) (2010), 0 descendants of its own

## Indications for use
The Small Vein Inhsion Set with Antineedle Stick Protector is a single use, sterile device used for peripheral venous access for solution administration or blood collection. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. The Winged Collection Set with Multi-Sample Luer Adapter and Antineedle Stick Protector is a single use, sterile, blood collection device used for peripheral venous access for blood sampling. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles.

Source page: https://510kreport.com/device/K023917
Methodology: https://510kreport.com/methodology