# K051783: Artsana Pen Needles, Artsana Injection Needles

- Pathway: 510(k) (Traditional)
- Applicant: Artsana S.P.A
- Decided: Oct 4, 2005 after 95 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
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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
- K110606: MV Intradermic Needles; Magic Needle; Magic Needle (2011), 2 descendants of its own
- K210059: Promisemed Insulin Pen Needle (2021), 1 descendant of its own
- K193422: Easydrip Pen Needle, Easydrip Plus Pen Needle (2021), 1 descendant of its own

## Indications for use
Artsana disposable sterile hypodermic needles are intended for use to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. Artsana disposable sterile pen needles are used with insulin pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.

Source page: https://510kreport.com/device/K051783
Methodology: https://510kreport.com/methodology