# K122767: Nmi Port

- Pathway: 510(k) (Abbreviated)
- Applicant: Navilyst Medical, Inc.
- Decided: Apr 30, 2013 after 232 days
- Product code: LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5965
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 31 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030083: Vaxcel with Pasv Port, Boston Scientific Corp (2003) Summary page 1.
- K031844: Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238, Boston Scientific Corp (2003) Summary page 1.
- K032008: Vaxcel with Pasv Port, Model 45-213, Boston Scientific Corp (2003) Summary page 1.
- K032375: Vaxcel Port, Models 45-336 and 45-338, Boston Scientific Corp (2003) Summary page 1.
- K032600: Vaxcel Port, Model 45-333 and Vaxcel W/Pasv Port, Model 45-233, Boston Scientific Corp (2003) Summary page 1.
- K071993: T-Port HP Infusion Port, Pfm Medical, Inc. (2007) Summary page 1.
- K072481: Jet Port Plus HP Catheter System, Pfm Medical, Inc. (2008) Summary page 1.
- K073210: Modification to: T-Port HP Infusion Port, Pfm Medical, Inc. (2007) Summary page 1.

## Most influential descendants
- K131694: Nmi Port II Catheter (2013), 2 descendants of its own
- 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
- Sep 18, 2019 · Class II · Z-0505-2020: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port cha
- Sep 18, 2019 · Class II · Z-0501-2020: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port cha
- Sep 18, 2019 · Class II · Z-0502-2020: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port cha
- Sep 18, 2019 · Class II · Z-0504-2020: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port cha
- Sep 18, 2019 · Class II · Z-0503-2020: Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port cha
- 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 Ports 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 Ports 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/K122767
Methodology: https://510kreport.com/methodology