# K120191: Push-on Needle 30GX8MM

- Pathway: 510(k) (Traditional)
- Applicant: Scandinavian Health Limited
- Decided: May 23, 2012 after 121 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
Longest line of descent: 5 generations back to K951254 (1995). 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)
- K093109: Novotwist Needle, Models 30G  * 8MM (1/3) 32 G Tip * 5 MM (1/5'), Novo Nordisk, Inc. (2010) Summary page 1.
- K080904: Feel-Fine Insulin Pen Needle, Feel Tech (2008) Summary page 1.

## Indications for use
Push-On Needle is intended for hypodermic injection of fluids into the body when attached to a compatible auto injector.

Source page: https://510kreport.com/device/K120191
Methodology: https://510kreport.com/methodology