# K080544: Unassigned

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Aug 14, 2008 after 169 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.
6 later devices descend from it; 2 cite it directly.
0 of 30 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 1.

## Most influential descendants
- K132880: Medcomp Power Injectable Safety Huber Needle (2014), 2 descendants of its own
- K111101: Norport CT-PC, Lucent Non-Coring Needel Infusion Set (2011), 2 descendants of its own
- K162271: Pro-Lock CT Safety Infusion Set (2017), 1 descendant of its own
- K112713: Norfolk Medical-Sportport-Family of Ports (2011), 1 descendant of its own
- K192291: TidalPort-AP Implantable Apheresis Vascular Access Port (2020), 0 descendants of its own

## Indications for use
The CT Injectable Safety Huber Needle is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The CT Injectable Safety Huber Needle incorporates an active safety feature that aids in the prevention of accidental needle sticks. The CT Injectable Safety Huber Needle is a safety needle designed with an anti-coring needle tip configuration. The primary use for Huber Needles is to deliver solutions to implanted ports. The safety feature is designed to protect the practitioner from accidental needle sticks. The CT Injectable Safety Huber Needle is compatible with power injection procedures up to 300 psi.

Source page: https://510kreport.com/device/K080544
Methodology: https://510kreport.com/methodology