# K150448: NMI PICC III and NMI PICC IV

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Mar 19, 2015 after 27 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K001901 (2000). 47 ancestors in all.
No later device cites it as a predicate yet.
2 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140266: Nmi Picc IV, Navilyst Medical, Inc. (2014) Summary page 4.
- K131942: Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter, Navilyst Medical, Inc. (2013) Summary page 4.

## Recalls of this device
- May 10, 2018 · Class II · Z-2205-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2192-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2211-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2207-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2195-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2209-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2208-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2206-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2214-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2204-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2215-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- Nov 28, 2016 · Class II · Z-0246-2018: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Gre
- Nov 28, 2016 · Class II · Z-0248-2018: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Gre
- Nov 28, 2016 · Class II · Z-0251-2018: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Gre
- Nov 28, 2016 · Class II · Z-0245-2018: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Gre
- Nov 28, 2016 · Class II · Z-0252-2018: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Gre
- Nov 28, 2016 · Class II · Z-0244-2018: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Gre
- Nov 28, 2016 · Class II · Z-0247-2018: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Gre
- Nov 28, 2016 · Class II · Z-0249-2018: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Gre
- Nov 28, 2016 · Class II · Z-0250-2018: Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Gre

## Indications for use
The NMI PICC III and NMI PICC IV are indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media. The NMI PICC IIT with PASV Valve Technology is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.

Source page: https://510kreport.com/device/K150448
Methodology: https://510kreport.com/methodology