# K132880: Medcomp Power Injectable Safety Huber Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Jan 8, 2014 after 117 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: 9 generations back to K001901 (2000). 24 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080544: Unassigned, Medcomp (2008) Summary page 5.

## Most influential descendants
- K162271: Pro-Lock CT Safety Infusion Set (2017), 1 descendant of its own
- K171333: 20G x 5/8 Pro-Lock CT Safety Infusion Set (2017), 0 descendants of its own

## Indications for use
The Medcomp® Power Injectable Huber Needle Safety Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through implanted vascular access ports. The Medcomp® Power Injectable Huber Needle Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/sec for 19 gauge and 20 gauge non-coring Huber style needles and 2 ml/sec for 22 gauge non-coring Huber style needles.

Source page: https://510kreport.com/device/K132880
Methodology: https://510kreport.com/methodology