# K122402: LPP (Low Profile Port)

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Jul 16, 2013 after 343 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072481: Jet Port Plus HP Catheter System, Pfm Medical, Inc. (2008) Summary page 1.

## Indications for use
The Low Profile Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples. When used with a power injectable needle, the Low Profile Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 3 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.

Source page: https://510kreport.com/device/K122402
Methodology: https://510kreport.com/methodology