# K090117: Autosafe-Reflex Safety Huber Infusion Set, Autosafe Advantage Safety Huber Infusion Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Autosafe-Reflex, Inc.
- Decided: Sep 29, 2009 after 251 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
AutoSafe Safety Huber Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implantable vascular ports Additionally, the passive needle safety shield is designed to help prevent needlestick injuries by shielding the needle between steps and after use.

Source page: https://510kreport.com/device/K090117
Methodology: https://510kreport.com/methodology