# K142616: PICC Maximal Barrier Nursing Kit - Pathway: 510(k) (Special) - Applicant: Navilyst Medical, Inc. - Decided: Oct 14, 2014 after 28 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: 13 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 12 generations back to K001901 (2000). 45 ancestors in all. 2 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) - K131038: Nmi Picc Maximal Barrier Nursing Kits, Navilyst Medical, Inc. (2013) Summary page 7. ## Most influential descendants - 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 - May 10, 2018 · Class II · Z-2193-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - May 10, 2018 · Class II · Z-2194-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - May 10, 2018 · Class II · Z-2191-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - May 10, 2018 · Class II · Z-2210-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - May 10, 2018 · Class II · Z-2203-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - May 10, 2018 · Class II · Z-2190-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - May 10, 2018 · Class II · Z-2196-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - May 10, 2018 · Class II · Z-2189-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens). - Aug 29, 2016 · Class II · Z-0708-2017: Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves suppl - Aug 29, 2016 · Class II · Z-0709-2017: Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves suppl - Aug 29, 2016 · Class II · Z-0710-2017: Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves suppl - Jun 8, 2016 · Class II · Z-0714-2017: There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, t - Jun 8, 2016 · Class II · Z-0715-2017: There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, t ## Indications for use The NMI PICC I1I is indicated for short-term 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 mjection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring. The maximum power injection flow rate for the NMI PICC III 1s 6 mL/sec. NON-VALVED VERSION The NMI PICC 111 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 em 1 mL/sec * 4F Single Lumen/55 cm 3.5 mL/sec * SF 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 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 The Xcela Hybrid PICC with PASV 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 mnjection 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 1s 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/K142616 Methodology: https://510kreport.com/methodology