# K132177: Medcomp Gen Iii Power Injectable Port

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp ( Medical Components)
- Decided: Dec 12, 2013 after 150 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 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.

## Recalls of this device
- Jan 13, 2021 · Class II · Z-1184-2021: The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem becaus
- Nov 22, 2017 · Class II · Z-1271-2018: The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
- May 25, 2017 · Class II · Z-0533-2018: The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
- Feb 23, 2017 · Class II · Z-1536-2017: The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introd

## Indications for use
The Medcomp® Gen III Power Injectable 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 infusion port 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.

Source page: https://510kreport.com/device/K132177
Methodology: https://510kreport.com/methodology