# K051009: Huber Clear Safety Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Now Medical Distribution, Inc.
- Decided: Jul 12, 2005 after 82 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: 2 generations back to K890127 (1989). 6 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993848: Millennium Huber Plus Safety Infusion Set, Millennium Medical Distribution, Inc. (2000) Summary page 1.

## Most influential descendants
- K082306: Powerloc Clear Safety Infusion Set (2008), 4 descendants of its own
- K111101: Norport CT-PC, Lucent Non-Coring Needel Infusion Set (2011), 2 descendants 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
- K120261: PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI Pressure Injectable Safety Huber (2012), 0 descendants of its own

## Indications for use
The NOW Huber Clear TM Safety Infusion Set is a safety IV administration set with a non-coring, ninety-degree, right-angle Huber needle, used to access surgically implanted vascular ports. The Huber needle is used to administer fluids or to withdraw blood. The Huber Clear TM system facilitates safe removal of the needle by encapsulating the needle within the attachment wings to help prevent needlestick injuries when using the device for vascular port access.

Source page: https://510kreport.com/device/K051009
Methodology: https://510kreport.com/methodology