# K131694: Nmi Port II Catheter

- Pathway: 510(k) (Abbreviated)
- Applicant: Navilyst Medical, Inc.
- Decided: Aug 8, 2013 after 59 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 67 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 70 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 1.
- K121089: Nmi Picc Iii, Navilyst Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K190559: SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (2020), 0 descendants of its own
- K153228: NMI Port, NMI Port II (2015), 0 descendants of its own

## Recalls of this device
- Jul 24, 2018 · Class II · Z-0076-2019: BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F S
- Nov 25, 2013 · Class II · Z-0826-2014: Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier.

## Indications for use
The NMI Port 11 with and without PASV Valve Technology is 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 11 is indicated for power injection of contrast media. The maximum recommended infusion rate is 5 mi/sec with a 19G or 20G non-coring power injectable needle or 2 mI/sec with a 220 non-coring power injectable needle.

Source page: https://510kreport.com/device/K131694
Methodology: https://510kreport.com/methodology