# K210258: NovoFine

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk, Inc.
- Decided: Jun 23, 2021 after 142 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173479: NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall), Novo Nordisk, Inc. (2018) Summary page 4.

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

Source page: https://510kreport.com/device/K210258
Methodology: https://510kreport.com/methodology