# K001043: Kawasumi Laboratory Blood Drawing Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kawasumi Laboratories America, Inc.
- Decided: May 19, 2000 after 49 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K073257: Kawasumi Laboratories Large Wing Sets with Antineedle Stick Protector (2008), 2 descendants of its own
- K102994: K-Shield Arterial Venous Fistula Set with Antineedle Stick Protector (2010), 1 descendant of its own
- K172957: Kawasumi Laboratories Blood Drawing Kit (BDK) System (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K001043
Methodology: https://510kreport.com/methodology