# K090111: Flexpen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk, Inc.
- Decided: Feb 1, 2010 after 381 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: 3 generations back to K951254 (1995). 6 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 23 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.
- K053470: Novofine 32G Tip, Novo Nordisk, Inc. (2005) Summary page 1.
- 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
- K113186: Sterile Insulin Pen Needle (2012), 4 descendants of its own
- K093109: Novotwist Needle, Models 30G  * 8MM (1/3) 32 G Tip * 5 MM (1/5') (2010), 4 descendants of its own
- K133100: Carefine Pen Needle (2014), 3 descendants of its own
- K133738: Novofine Plus 32G 4 MM (2014), 2 descendants of its own
- K210748: Well-life TM Pen Needles, Well-life TM Safety Pen Needles (2022), 1 descendant of its own

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

Source page: https://510kreport.com/device/K090111
Methodology: https://510kreport.com/methodology