# K021565: Luther Safety Huber Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Luther Research Partners
- Decided: Nov 14, 2002 after 185 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.
17 later devices descend from it; 4 cite it directly.
0 of 24 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
- K040527: Low Profile Luther Safety Huber (2004), 14 descendants of its own
- K073050: Safestep Max Power-Injectable Infusion Set (2008), 13 descendants of its own
- K170897: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site (2017), 6 descendants of its own
- K032934: MPS Acacia Safeguard Huber Device (2003), 3 descendants of its own
- K230715: Promisemed Safety Huber Needle (2023), 2 descendants of its own

## Indications for use
The Luther Safety Huber Needle Set is a device intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.

Source page: https://510kreport.com/device/K021565
Methodology: https://510kreport.com/methodology