# K153228: NMI Port, NMI Port II

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Dec 4, 2015 after 28 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: 12 generations back to K001901 (2000). 68 ancestors in all.
No later device cites it as a predicate yet.
2 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122767: Nmi Port, Navilyst Medical, Inc. (2013) Summary page 4.
- K131694: Nmi Port II Catheter, Navilyst Medical, Inc. (2013) Summary page 4.

## Indications for use
The NMI Port and NMI Port II with and without PASV Valve Technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. When used with a power injectable needle, the NMI Port and NMI Port II are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 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/K153228
Methodology: https://510kreport.com/methodology