# K163452: PICC Maximal Barrier Nursing Kit

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Feb 3, 2017 after 56 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: 13 generations back to K001901 (2000). 46 ancestors in all.
1 later device descends 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)
- K142616: PICC Maximal Barrier Nursing Kit, Navilyst Medical, Inc. (2014) Summary page 6.

## Most influential descendants
- 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
- May 10, 2018 · Class II · Z-2222-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2224-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2223-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2217-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2221-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).

## Indications for use
The PICC Maximal Barrier Nursing Kit with BioFlo Hybrid PICC with Endexo Technology and 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. 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. The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo 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. 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 – 6 mL/sec The PICC Maximal Barrier Nursing Kit with BioFlo PICC with Endexo Technology and 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 The Maximal Barrier Nursing Kit with BioFlo Midline Catheter is indicated for short term access (< 30 days) to the peripheral venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and the sampling of blood and blood products. Maximum Power Injection Flow Rates: • 3F Single Lumen, 20 cm: 2 mL/sec • 4F Single Lumen, 20 cm: 6 mL/sec • 5F Single Lumen, 20 cam: 6 mL/sec • 5F Dual Lumen, 20 cm: 6 mL/sec The PICC Maximal Barrier Nursing Kit with Xcela Hybrid PICC 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. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the Xcela Hybrid PICC with PASV Valave Technology is 6 mL/sec. The PICC Maximal Barrier Nursing Kit with Xcela PICC 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. The PICC Maximal Barrier Nursing Kit with Xcela Power Injectable PICC 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.

Source page: https://510kreport.com/device/K163452
Methodology: https://510kreport.com/methodology