# K231255: NovoFine® Plus

- Pathway: 510(k) (Special)
- Applicant: Novo Nordisk, Inc.
- Decided: Aug 25, 2023 after 116 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: 7 generations back to K951254 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202005: NovoFine Plus 32G Tip x 4 mm, Novo Nordisk, Inc. (2020) Summary page 4.

## Indications for use
Indications for Use: NovoFine® Plus needles are intended for use with pen injector devices for the subcutaneous injection of drugs.

Source page: https://510kreport.com/device/K231255
Methodology: https://510kreport.com/methodology