# K062500: Flexpen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk, Inc.
- Decided: Nov 21, 2006 after 88 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: 2 generations back to K951254 (1995). 5 ancestors in all.
17 later devices descend from it; 3 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)
- K053470: Novofine 32G Tip, Novo Nordisk, Inc. (2005) Summary page 1.
- K050106: Novofine Autocover 30G X 8MM, Novo Nordisk, Inc. (2005). Our reading of the summary gave K000106, FDA’s number for Depilase Yaglase ND:Yag Laser System and Accessories (Fotona D.D.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NovoFine 7 Autocover 30G x 8 mm”.
- K051899: BD Pen Needle, Becton, Dickinson & CO (2005) Summary page 1.

## Most influential descendants
- K090111: Flexpen Needle (2010), 16 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K062500
Methodology: https://510kreport.com/methodology