# K180546: Jet Power Injectable PICC

- Pathway: 510(k) (Traditional)
- Applicant: Jet Medical, Inc.
- Decided: Nov 21, 2018 after 265 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: 9 generations back to K001901 (2000). 25 ancestors in all.
No later device cites it as a predicate yet.
2 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091953: Pro-Picc, Medcomp (2009) Summary page 4.

## Indications for use
The Jet Power Injectable PICC is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter, The maximum recommended infusion rate for the 3F Jet Power Injectable PICC is 1cc/sec and 5.0cc/sec for the 4F and 5F Jet Power Injectable PICC.

Source page: https://510kreport.com/device/K180546
Methodology: https://510kreport.com/methodology