# K141146: Invisiport

- Pathway: 510(k) (Special)
- Applicant: Stealth Therapeutics, Incorporated
- Decided: May 1, 2015 after 361 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.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110407: Invisiport, Stealth Therapeutics, Incorporated (2011) Summary page 4.

## Indications for use
The Invisiport is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, or the sampling of blood, or for power injection of contrast media when used with a power-injectable Huber needle or infusion set.

Source page: https://510kreport.com/device/K141146
Methodology: https://510kreport.com/methodology