# K073339: Blood Component Recipient Set with Standard Size Filter and Infusion Set with Side Arm Luer Connector

- Pathway: 510(k) (Traditional)
- Applicant: Fenwal, Inc.
- Decided: Mar 3, 2008 after 96 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 K811078 (1981). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881321: Blood/Solution Set W/Pressure Pump, Baxter Healthcare Corp (1988) Summary page 1.
- K811078: Radiation Sterilized Admin. Set, Travenol Laboratories, S.A. (1981) Summary page 1.

## Most influential descendants
- K111702: Amicus Separator System- Use in Therapeutic Plasma Exchange and Filter Set for Amicus Tpe (2012), 2 descendants of its own
- K141019: Amicus Separator System/ Amicus Seperator System;Refurbished (2014), 1 descendant of its own
- K162462: AMICUS Separator System, AMICUS Separator System; Refurbished (2016), 0 descendants of its own

## Indications for use
Administration of blood and blood by-products.

Source page: https://510kreport.com/device/K073339
Methodology: https://510kreport.com/methodology