# K121089: Nmi Picc Iii

- Pathway: 510(k) (Traditional)
- Applicant: Navilyst Medical, Inc.
- Decided: Aug 23, 2012 after 135 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: 9 generations back to K001901 (2000). 41 ancestors in all.
23 later devices descend from it; 6 cite it directly.
3 of 65 devices in its family (counting itself) have 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.
- K101326: NMI IC, Navilyst Medical, Inc. (2010) Summary page 1.
- K091261: Nmi Picc, Navilyst Medical, Inc. (2009) Summary page 1.
- K093366: Nmi Picc II, Navilyst Medical, Inc. (2009) Summary page 1.
- K083763: Zeus CT Picc 4 FR and 5 FR Single and Dual Lumen, R4 Vascular, Inc. (2009) Summary page 1.

## Most influential descendants
- 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
- K133264: Nmi Picc Iii (2013), 6 descendants of its own
- K172885: HydroPICC (2018), 5 descendants of its own
- K193015: HydroPICC (PICC-142) (2020), 4 descendants of its own

## Indications for use
NON-VALVED VERSION 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: -4F Single Lumen/55 cm - 3.5 mL/sec -5F Single Lumen/55 cm - 5 mL/sec *5F7 Dual Lumen/55 cm - 4 mL/sec *6F Dual Lumenl5 cm - 5 mL/sec VALVED VERSION The NMI P1CC III 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 and for power injection of contrast media. Maximum Power Injection Flow Rate: -3F Single Lumen/55 cm - I mL/sec -4F Single Lumen/55 cat - 3.5 mL/sec *5F Single LumenISS cm- 5 mL/sec -517 Dual Lumen/55 cm - 4 mL/sec 617 Dual LumenISS cm - 5 mL/sec *6F Triple Lumen/S 5 cm - 6 mL/sec

Source page: https://510kreport.com/device/K121089
Methodology: https://510kreport.com/methodology