# K172957: Kawasumi Laboratories Blood Drawing Kit (BDK) System

- Pathway: 510(k) (Traditional)
- Applicant: Kawasumi Laboratories, Inc.
- Decided: Sep 28, 2018 after 367 days
- Product code: KSB (Set, Transfer (Blood/Plasma))
- Device class: 2
- Regulation: 21 CFR 864.9875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970259 (1997). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001043: Kawasumi Laboratory Blood Drawing Kit, Kawasumi Laboratories America, Inc. (2000) Summary page 4.
- K073257: Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector, Kawasumi Laboratories, Inc. (2008) Summary page 6.
- K102994: K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector, Kawasumi Laboratories, Inc. (2010) Summary page 6.

## Indications for use
The Blood Drawing Kit with Antineedle Stick Protector is a single use, sterile transfer set designed for vascular access for blood withdrawal. Use of the Needleless Access Connector allows the clinician needle-free blood withdrawal when blood sampling is required. The Antineedle Stick Protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield needles. This device is not intended for blood transfusion.

Source page: https://510kreport.com/device/K172957
Methodology: https://510kreport.com/methodology