# K202005: NovoFine Plus 32G Tip x 4 mm

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk, Inc.
- Decided: Dec 19, 2020 after 151 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: 6 generations back to K951254 (1995). 11 ancestors in all.
1 later device descends 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)
- K133738: Novofine Plus 32G 4 MM, Novo Nordisk, Inc. (2014) Summary page 6.

## Most influential descendants
- K231255: NovoFine® Plus (2023), 0 descendants of its own

## Indications for use
NovoFine® Plus 32 G 4mm is intended for use with pen injector devices for the subcutaneous injection of drugs.

Source page: https://510kreport.com/device/K202005
Methodology: https://510kreport.com/methodology