# K040533: EZ Huber Safety Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Sep 17, 2004 after 200 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: 1 generation back to K002471 (2000). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002471: Jetcan Huber Neeedle Set, Pfm Produkte Fur Die Medizin AG (2000) Summary page 1.

## Most influential descendants
- K071846: Modification to EZ Huber Safety Infusion Set (2007), 8 descendants of its own
- K080544: Unassigned (2008), 6 descendants of its own
- 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

## Indications for use
The EZ Huber Safety Infusion Set is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The EZ Huber Safety infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks.

Source page: https://510kreport.com/device/K040533
Methodology: https://510kreport.com/methodology