# K010189: Vortex Access System

- Pathway: 510(k) (Special)
- Applicant: Horizon Medical Products, Inc.
- Decided: Feb 12, 2001 after 21 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K032557: Triumph VTX with Lifevalve Catheter (2003), 7 descendants of its own
- K081472: Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile Titanium Ports (2008), 4 descendants of its own
- K102385: Norfolk Medical Norport Family of Ports (2011), 3 descendants of its own
- K111101: Norport CT-PC, Lucent Non-Coring Needel Infusion Set (2011), 2 descendants of its own
- K112713: Norfolk Medical-Sportport-Family of Ports (2011), 1 descendant of its own

## Recalls of this device
- Sep 27, 2010 · Not classified · Z-0402-2011: Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.
- Oct 3, 2007 · Not classified · Z-0149-2008: Incorrect Size Catheter: The product may contain an incorrect size catheter.

Source page: https://510kreport.com/device/K010189
Methodology: https://510kreport.com/methodology