# K133738: Novofine Plus 32G 4 MM

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk, Inc.
- Decided: May 21, 2014 after 163 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). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090111: Flexpen Needle, Novo Nordisk, Inc. (2010) Summary page 2.
- K093109: Novotwist Needle, Models 30G  * 8MM (1/3) 32 G Tip * 5 MM (1/5'), Novo Nordisk, Inc. (2010) Summary page 2.
- K123300: BD Pen Needle, Becton, Dickinson & CO (2013) Summary page 2.

## Most influential descendants
- K202005: NovoFine Plus 32G Tip x 4 mm (2020), 1 descendant of its own
- K231255: NovoFine® Plus (2023), 0 descendants of its own

## Indications for use
NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs, including insulin, GLP-1 analogs, and somatropin.

Source page: https://510kreport.com/device/K133738
Methodology: https://510kreport.com/methodology