# K113225: Nylus Picc

- Pathway: 510(k) (Traditional)
- Applicant: Semprus Biosciences
- Decided: Nov 6, 2012 after 371 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: 11 generations back to K001901 (2000). 35 ancestors in all.
No later device cites it as a predicate yet.
2 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101329: Synergy CT Picc, Health Line International Corporation (2010) Summary page 2.
- K083763: Zeus CT Picc 4 FR and 5 FR Single and Dual Lumen, R4 Vascular, Inc. (2009) Summary page 2.
- K091506: Duraspan Hemodialysis Long-Term Catheter, Models 62152420, 621512820, 62153220, 62153620, 62154020, 62155520, R4 Vascular, Inc. (2010) Summary page 2.

## Indications for use
The Nylus P1CC is intended to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The Nylus P1CC is indicated for dwell times shorter or greater than 30 days. The device has a maximum recommended infusion rating of 5mL/sec.

Source page: https://510kreport.com/device/K113225
Methodology: https://510kreport.com/methodology