# K994323: Kawasumi Laboratories Philebotomy Set

- Pathway: 510(k) (Traditional)
- Applicant: Kawasumi Laboratories Co., Ltd.
- Decided: Mar 8, 2000 after 77 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- 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.
3 later devices descend from it; 1 cites 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. The FDA summary names its predicate without a number.
- (no number) Abbott Laboratories Blood Collection Set: named in the summary without a submission number

## 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

## Indications for use
A CONDUIT FOR BLOOD REMOVAL FROM A PATIENT TO A VACUUM BOTTLE TO AID IN THE TREATMENT OF A DISEASE OR OTHER CONDITION.

Source page: https://510kreport.com/device/K994323
Methodology: https://510kreport.com/methodology