# K042666: Luth-All Sub-Q Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Luth-All Medical Products, LLC
- Decided: Dec 21, 2004 after 83 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: 3 generations back to K831445 (1983). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 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.
- K020530: Evans Sub-Q, Model MC4206, Evans Medical, Inc. (2002) Summary page 1.

## Indications for use
The Luth-All Safety Sub-Q Needle Set is a device intended to administer drugs to a patient from a container by infusion subcutaneously. It is manufactured with conventional medical grade, biocompatible materials. It operates as a standard safety needle with the addition of a built in active safety feature, which when activated the device is designed to aid in reducing the possibility of accidental needle sticks.

Source page: https://510kreport.com/device/K042666
Methodology: https://510kreport.com/methodology