# K102994: K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector

- Pathway: 510(k) (Special)
- Applicant: Kawasumi Laboratories, Inc.
- Decided: Nov 3, 2010 after 26 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073257: Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector, Kawasumi Laboratories, Inc. (2008) Summary page 1.
- K932074: Medisystems Apheresis Needle with Guard, Medisystems Corp. (1994) Summary page 2.
- K980414: Vacutainer Brand Safety-Lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.

## Most influential descendants
- K172957: Kawasumi Laboratories Blood Drawing Kit (BDK) System (2018), 0 descendants of its own

## Indications for use
Name: Kawasumni A.V. Fistula Set Intended Use: This device is intended to be used to access a vein or artery and to be used as a conduit to connect to blood tubing lines for performing patient hemodialysis. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein or artery. Name: Kawasumni Laboratory Blood Drawing Kit Intended Use: This is a therapeutic device used to access a patients vein for blood removal from the patient to a blood bag reservoir to aid in the treatment of a disease or other condition. This device is not intended for blood transfusions. The device is designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein. Name: Kawasumi Laboratories Phlebotomy Set Intended Use: This device is intended to be used to access a patient's vein and as a conduit for blood removal to a vacuum bottle to aid in the treatment of a disease or other condition. The device is designddi with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the device is activated during removal from the patient's vein.

Source page: https://510kreport.com/device/K102994
Methodology: https://510kreport.com/methodology