# K220558: Blood Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Nov 17, 2022 after 262 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: 2 generations back to K993120 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210335: Blood Administration Set, Baxter Healthcare Corporation (2021) Summary page 5.

## Indications for use
Applicable to Product Code 2N3383: For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device. Applicable to Product Code 2N3385: For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device. Only for use with Neonates and Pediatrics. Not for use in Trauma situations.

Source page: https://510kreport.com/device/K220558
Methodology: https://510kreport.com/methodology