# K131038: Nmi Picc Maximal Barrier Nursing Kits

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: May 9, 2013 after 24 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: 12 (0 Class I)
- 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.
3 later devices descend from it; 1 cites it directly.
2 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122882: Nmi Hpicc Iii, Navilyst Medical, Inc. (2012) Summary page 1.
- K121089: Nmi Picc Iii, Navilyst Medical, Inc. (2012) Summary page 1.
- K111906: Xcela Hybrid Picc with Pasv Valve Technology, Navilyst Medical, Inc. (2011)
- K093366: Nmi Picc II, Navilyst Medical, Inc. (2009) Summary page 1.
- K091261: Nmi Picc, Navilyst Medical, Inc. (2009) Summary page 1.
- K070002: Boston Scientific Peripherally Inserted Central Catheter, Boston Scientific (2007) Summary page 1.

## Most influential descendants
- K142616: PICC Maximal Barrier Nursing Kit (2014), 2 descendants of its own
- K163452: PICC Maximal Barrier Nursing Kit (2017), 1 descendant of its own
- K252373: BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology (2025), 0 descendants of its own

## Recalls of this device
- Aug 25, 2014 · Class II · Z-0025-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0027-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0035-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0026-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0028-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0031-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0032-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0033-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0034-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0036-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0029-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se
- Aug 25, 2014 · Class II · Z-0030-2015: NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open se

## 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 * 5F Dual Lumen/55 cm 4 mL/sec * 6F Dual Lumen/55 cm 5 mL/sec VALVED VERSION The NMI PICC 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 1 mL/sec * 4F Single Lumen/55 cm 3.5 mL/sec * 5F Single Lumen/55 cm 5 mL/sec * 5F Dual Lumen/55 cm 4 mL/sec * 6F Dual Lumen/55 cm 5 mL/sec * 6F Triple Lumen/55 cm 6 mL/sec NON-VALVED VERSION 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 central venous pressure monitoring 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. 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 Xcela Hybrid PICC with PASV Valve Technology is 6 mL/sec. 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/K131038
Methodology: https://510kreport.com/methodology