# K162304: Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Dec 6, 2016 after 111 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: 3 generations back to K003225 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151079: Q2 Intravenous Adminstration Sets and Extension Sets, Quest Medical, Inc. (2015) Summary page 4.
- K800825: Extension Set Quest Code #3000, Quest Medical, Inc. (1980) Summary page 4.
- K040385: Multiport Manifold Set with Swabable Valves, Model 9900, Quest Medical, Inc. (2004) Summary page 4.

## Indications for use
The Q2 and CheckMate Multiport IV Administration Sets and Extension Sets are indicated for use for the following: For administration of intravenous fluids to a patient’s vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Source page: https://510kreport.com/device/K162304
Methodology: https://510kreport.com/methodology