# K002689: Swabsite Swabbable Valve, Model 245000

- Pathway: 510(k) (Traditional)
- Applicant: Quest Medical, Inc.
- Decided: Mar 6, 2001 after 189 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: 2 generations back to K901063 (1990). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970485: Smartsite Access Pin, Ivac Medical Systems (1997) Summary page 1.

## Most influential descendants
- K120548: Hlic Needle-Less Valve (2012), 0 descendants of its own
- K112073: Infusite Needleless Acces Device (Sterile, Bulk Non-Sterile) and Infusite Needleless Access Device 'Y' Adapter (Bulk... (2012), 0 descendants of its own
- K061143: Robertsite Stopcock (2006), 0 descendants of its own

## Indications for use
The SWABSITE injection port is an IV administration set accessory that allows needleless luer connections to luer access devices (syringes, etc.)

Source page: https://510kreport.com/device/K002689
Methodology: https://510kreport.com/methodology