# K131942: Nmi Picc Iii Catheter, Nmi Hpicc Iii Catheter

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Jul 31, 2013 after 34 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 44 ancestors in all.
7 later devices descend from it; 3 cite it directly.
2 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121089: Nmi Picc Iii, Navilyst Medical, Inc. (2012) Summary page 1.
- K122882: Nmi Hpicc Iii, Navilyst Medical, Inc. (2012) Summary page 1.

## Most influential descendants
- K133264: Nmi Picc Iii (2013), 6 descendants of its own
- K140266: Nmi Picc IV (2014), 3 descendants of its own
- K150527: Xcela Power Injectable PICC (2015), 1 descendant of its own
- K153469: Cathtong I PICC Catheter (2016), 0 descendants of its own
- K152409: Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC (2015), 0 descendants of its own

## Indications for use
The NMI PICC III 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. Maximum Power Injection Flow Rate Description — Flow Rate 4F Single Lumen - 55cm length — 3.5 mL/sec 5F Single Lumen - 55cm length — 5 mL/sec 5F Dual Lumen - 55 cm length — 4 mL/sec 6F Dual Lumen - 55cm length — 5 mL/sec The NMI PICC III with PASV Valve Technology is indicated for short- or long-term 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. Maximum Power Injection Flow Rate Description — Flow Rate 3F Single Lumen - 55cm length — 1 mL/sec 4F Single Lumen - 55cm length — 3.5 mL/sec 5F Single Lumen - 55cm length — 5 mL/sec 5F Dual Lumen - 55cm length — 4 mL/sec 6F Dual Lumen - 55cm length — 5 mL/sec 6F Triple Lumen - 55cm length — 6 mL/sec The NMI HPICC III 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, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.

Source page: https://510kreport.com/device/K131942
Methodology: https://510kreport.com/methodology