# K120281: Dignity Power Injectable Titanium Port

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Sep 17, 2012 after 230 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K001901 (2000). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070003: Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and Pre-Attached), Medcomp (2007) Summary page 1.
- K111424: Vacuette Premium Safety Needle System Tube-Touch, Medpro Safety Products, Inc. (2011) Summary page 1.
- K091099: C-Port - HP Power Injectable Port, Phs Medical GmbH (2009) Summary page 1.

## Indications for use
The CT Power Injectable Implantable Infusion Port is 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. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 mL/s with a 22 gauge non-coring power injectable needle.

Source page: https://510kreport.com/device/K120281
Methodology: https://510kreport.com/methodology