# K053470: Novofine 32G Tip

- Pathway: 510(k) (Special)
- Applicant: Novo Nordisk, Inc.
- Decided: Dec 21, 2005 after 7 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: 1 generation back to K002403 (2000). 1 ancestor in all.
18 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002403: Novofine 31 Disposable Needle, Novo Norodisk Pharmaceuticals, Inc. (2000) Summary page 1.

## Most influential descendants
- K062500: Flexpen Needle (2006), 17 descendants of its own
- 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

## Indications for use
NovoFine® 32G Tip needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products.

Source page: https://510kreport.com/device/K053470
Methodology: https://510kreport.com/methodology