# K213846: Q2 Blood Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Jun 5, 2022 after 177 days
- Product code: FPA (Set, Administration, Intravascular)
- 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: 4 generations back to K030467 (2003). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143082: IV Administration Sets with 200(micro)m Blood Filter, B.Braun Medical, Inc. (2015) Summary page 5.

## Indications for use
The Blood Administration Sets are used to deliver blood, blood components, and IV fluids from a container to a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and the duration of therapy.

Source page: https://510kreport.com/device/K213846
Methodology: https://510kreport.com/methodology