# K210335: Blood Administration Set

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corporation
- Decided: Jun 10, 2021 after 125 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 K993120 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993120: Modified Blood Recipient Set, Baxter Healthcare Corp (1999) Summary page 5.

## Most influential descendants
- K220558: Blood Administration Sets (2022), 0 descendants of its own

## Indications for use
For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.

Source page: https://510kreport.com/device/K210335
Methodology: https://510kreport.com/methodology