# K040527: Low Profile Luther Safety Huber

- Pathway: 510(k) (Special)
- Applicant: Luther Needlesafe Products, Inc.
- Decided: Mar 26, 2004 after 25 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K890127 (1989). 7 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021565: Luther Safety Huber Needle Set, Luther Research Partners (2002) Summary page 1.

## Most influential descendants
- 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
- K230715: Promisemed Safety Huber Needle (2023), 2 descendants of its own
- K200463: Huber Needle Infusion Set, Safety Huber Needle Infusion Set (2021), 2 descendants of its own
- K153440: PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set (2016), 2 descendants of its own

## Recalls of this device
- Dec 19, 2016 · Class II · Z-0986-2017: Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may 
- Aug 8, 2014 · Class II · Z-1273-2015: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of 

## Indications for use
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/K040527
Methodology: https://510kreport.com/methodology