# K091261: Nmi Picc

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: May 12, 2009 after 13 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K041420 (2004). 4 ancestors in all.
27 later devices descend from it; 5 cite it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070002: Boston Scientific Peripherally Inserted Central Catheter, Boston Scientific (2007) Summary page 1.
- K021704: Vaxcel Picc with Pasv Valve Technology, Catheter Innovations, Inc. (2002) Summary page 1.

## Most influential descendants
- K093366: Nmi Picc II (2009), 26 descendants of its own
- K121089: Nmi Picc Iii (2012), 23 descendants of its own
- K111906: Xcela Hybrid Picc with Pasv Valve Technology (2011), 14 descendants of its own
- K122882: Nmi Hpicc Iii (2012), 12 descendants of its own
- K131942: Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter (2013), 7 descendants of its own

## Recalls of this device
- Oct 16, 2018 · Class II · Z-0595-2019: Specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by v
- Nov 28, 2016 · Class II · Z-0240-2018: 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-0242-2018: 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-0241-2018: 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-0243-2018: 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
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; and for power injection of contrast media.

Source page: https://510kreport.com/device/K091261
Methodology: https://510kreport.com/methodology