# K042917: Stat Medical Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Emergogroup, Inc.
- Decided: Apr 22, 2005 after 182 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K092016: Super-Fine Pen Needle (2009), 0 descendants of its own

## Indications for use
The Stat Medical Pen Needle is a single use device intended for use with a pen injector device for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K042917
Methodology: https://510kreport.com/methodology