# K242763: JetCan® Pro Safety Huber Needle

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: May 2, 2025 after 232 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001901 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071846: Modification to EZ Huber Safety Infusion Set, Pfm Medical, Inc. (2007) Summary page 5.

## Indications for use
The JetCan® Pro Safety Huber Needle is indicated for use in the delivery of fluids and drugs, as well as blood sampling through surgically implanted vascular access ports for up to 24 hours. It is compatible with power injection ports and associated power injection procedures up to 325 psi. The JetCan® Pro Safety Huber Needle incorporates a passive safety mechanism, activated upon the withdrawal from a port catheter to aid in the prevention of accidental needle sticks and minimize exposure to hazardous fluids.

Source page: https://510kreport.com/device/K242763
Methodology: https://510kreport.com/methodology