# K213588: Q2 IV Administration Sets

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Jun 2, 2022 after 202 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: 6 generations back to K904518 (1990). 29 ancestors in all.
No later device cites it as a predicate yet.
4 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170595: IV Administration Sets, B.Braun Medical, Inc. (2017) Summary page 5.

## Indications for use
IV Administration Sets are intended for delivery of fluids from a container into 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 duration of therapy.

Source page: https://510kreport.com/device/K213588
Methodology: https://510kreport.com/methodology