# K040385: Multiport Manifold Set with Swabable Valves, Model 9900

- Pathway: 510(k) (Abbreviated)
- Applicant: Quest Medical, Inc.
- Decided: Apr 7, 2004 after 50 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: 1 generation back to K003225 (2000). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003225: Solution Administration Sets with Capless Luer Activated Valve, Baxter Healthcare Corp (2000) Summary page 1.

## Most influential descendants
- K151079: Q2 Intravenous Adminstration Sets and Extension Sets (2015), 1 descendant of its own
- K162304: Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets (2016), 0 descendants of its own
- K051943: Sureflow Safety Infusion Device (2005), 0 descendants of its own

## Indications for use
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. The needleless safety feature may aid in the prevention of needlestick injury.

Source page: https://510kreport.com/device/K040385
Methodology: https://510kreport.com/methodology