# K023039: Blood/Solution Administration Set, Model 33.015

- Pathway: 510(k) (Traditional)
- Applicant: Tuta Healthcare Pty Limited
- Decided: Nov 7, 2002 after 56 days
- Product code: BRZ (Set, Blood Transfusion)
- 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
Longest line of descent: 1 generation back to K924721 (1993). 1 ancestor in all.
2 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)
- K924721: Baxter Solution Administration Sets, Baxter Healthcare Corp (1993) Summary page 1.

## Most influential descendants
- K041496: Pentatrasfu  Blood Transfusion Sets (2005), 1 descendant of its own
- K083349: Blood Transfusion Set (2009), 0 descendants of its own

## Indications for use
Administration of Intravenous fluids and drugs. The Tuta Healthcare Ply. Limited Blood Administration Set is a device used to administer fluids, blood and blood products from a container to a patient's vascular system Through a catheter or venous access system inserted into a vein- Use of Needle-Frce Access site may aide in the prevention of needlestick injury.

Source page: https://510kreport.com/device/K023039
Methodology: https://510kreport.com/methodology