# K260916: FLEXI-PORT™ Power Injectable Implantable Port

- Pathway: 510(k) (Traditional)
- Applicant: Portal Access, Inc.
- Decided: Jun 17, 2026 after 90 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). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242328: PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports, Bard Access Systems, Inc. (2024) Summary page 5.

## Indications for use
The FLEXI-PORT Power Injectable Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medications (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for withdrawal of blood samples. When used with a power injectable needle, the FLEXI-PORT is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

Source page: https://510kreport.com/device/K260916
Methodology: https://510kreport.com/methodology