# K110424: Dignity Mini Port- Attachable; Dignity Mini Port- Pre Attached; Dignity Low Profile Port- Attachable; Dignity Low Profil

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp ( Medical Components)
- Decided: Nov 30, 2011 after 289 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: 8 generations back to K001901 (2000). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 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.
- K952435: Celsite Pediatric Venous System, B.Braun Medical, Inc. (1996) Summary page 1.

## Most influential descendants
- K121383: PS X Series (Basic Components and Catheter), PD X Series (Catheter with All Components) (2012), 0 descendants of its own

## Indications for use
The CT Power Injectable Implantable Infusion Ports are indicated for pediatric patient therapies requiring repeated access to the vascular system. The podt system can be used for infusion of medications. IN. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples. The maximum recommended infusion rate is 5 mi/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 mI/s with a 22 gauge non-coring power injectable needle,

Source page: https://510kreport.com/device/K110424
Methodology: https://510kreport.com/methodology