# K050310: Bardport Titanium Ports

- Pathway: 510(k) (Special)
- Applicant: Bard Access Systems, Inc.
- Decided: Apr 18, 2005 after 69 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
Longest line of descent: 1 generation back to K870260 (1987). 1 ancestor in all.
68 later devices descend from it; 3 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870260: Hickman Titanium Subcutaneous Port, C.R. Bard, Inc. (1987) Summary page 1.

## Most influential descendants
- K060812: Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple (2006), 66 descendants of its own
- K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached) (2007), 20 descendants of its own
- K062414: Vortex CT Port Access System and Lifeguard Safety Infusion Set (2007), 20 descendants of its own
- K070116: Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power Gripper Plus Needle (2007), 18 descendants of its own
- K073050: Safestep Max Power-Injectable Infusion Set (2008), 13 descendants of its own

## Recalls of this device
- Oct 1, 2019 · Class II · Z-1575-2020: Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This ca
- Aug 30, 2011 · Not classified · Z-3173-2011: Implanted port has discrepant product information on package labeling.

## Indications for use
The BardPort® Implanted Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

Source page: https://510kreport.com/device/K050310
Methodology: https://510kreport.com/methodology