# K050106: Novofine Autocover 30G X 8MM

- Pathway: 510(k) (Traditional)
- Applicant: Novo Nordisk, Inc.
- Decided: Mar 30, 2005 after 71 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 K951254 (1995). 2 ancestors in all.
34 later devices descend from it; 5 cite it directly.
0 of 37 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.
- K951254: Safetyglide Needle, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 1.

## Most influential descendants
- K062500: Flexpen Needle (2006), 17 descendants of its own
- K090111: Flexpen Needle (2010), 16 descendants of its own
- K151311: Safe Block Pen Needle (2016), 11 descendants of its own
- K161950: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle (2017), 9 descendants of its own
- K113186: Sterile Insulin Pen Needle (2012), 4 descendants of its own

## Indications for use
NovoFine® AutocoverTM 30G x 8 mm needles are used in conjunction with insulin injection delivery devices for subcutaneous administration of sterile parenteral insulin products. Additionally, after withdrawal of the needle from the body, the attached needle safety shield will automatically cover the needle to minimize the risk of accidental needlestick.

Source page: https://510kreport.com/device/K050106
Methodology: https://510kreport.com/methodology