# K121990: Picc Convenience Kit

- Pathway: 510(k) (Special)
- Applicant: Navilyst Medical, Inc.
- Decided: Aug 3, 2012 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: 17 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001901 (2000). 41 ancestors in all.
No later device cites it as a predicate yet.
2 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111906: Xcela Hybrid Picc with Pasv Valve Technology, Navilyst Medical, Inc. (2011) Summary page 1.
- K101326: NMI IC, Navilyst Medical, Inc. (2010) Summary page 1.
- 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.
- K021704: Vaxcel Picc with Pasv Valve Technology, Catheter Innovations, Inc. (2002) Summary page 1.

## Recalls of this device
- Oct 16, 2018 · Class II · Z-0596-2019: specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by v
- May 10, 2018 · Class II · Z-2213-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2201-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2200-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- May 10, 2018 · Class II · Z-2216-2018: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
- 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
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 P1CC 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. for use in establishing peripheral access to the central venous system for administration of fluids including, but nor limited to hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. The product is intended for central venous access in adults, children, and infants who require intravenous (IV) therapy.

Source page: https://510kreport.com/device/K121990
Methodology: https://510kreport.com/methodology