# K951814: Triumph-1 Port

- Pathway: 510(k) (Traditional)
- Applicant: Horizon Medical Products, Inc.
- Decided: Aug 29, 1995 after 133 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, 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
- K043178: Grantalder Rhapsody Access Port and Catheter (2006), 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

## Recalls of this device
- Sep 27, 2010 · Not classified · Z-0406-2011: Labeling Error; The labeling for the specific products incorrectly identified that the packaged device kit contains a Lifeguard Safety Infusion Set.

Source page: https://510kreport.com/device/K951814
Methodology: https://510kreport.com/methodology