# K093109: Novotwist Needle, Models 30G  * 8MM (1/3) 32 G Tip * 5 MM (1/5')

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk, Inc.
- Decided: Jun 18, 2010 after 260 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: 4 generations back to K951254 (1995). 7 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062500: Flexpen Needle, Novo Nordisk, Inc. (2006) Summary page 1.
- K090111: Flexpen Needle, Novo Nordisk, Inc. (2010). Cleared while this submission was under review
- K050106: Novofine Autocover 30G X 8MM, Novo Nordisk, Inc. (2005) Summary page 1.
- K051899: BD Pen Needle, Becton, Dickinson & CO (2005) Summary page 1.

## Most influential descendants
- K133738: Novofine Plus 32G 4 MM (2014), 2 descendants of its own
- K202005: NovoFine Plus 32G Tip x 4 mm (2020), 1 descendant of its own
- K231255: NovoFine® Plus (2023), 0 descendants of its own
- K120191: Push-on Needle 30GX8MM (2012), 0 descendants of its own

## Indications for use
NovoTwist® needles are intended for use with pen injector devices for the subcutaneous injection of insulin, liraglutide and somatropin

Source page: https://510kreport.com/device/K093109
Methodology: https://510kreport.com/methodology