# K092016: Super-Fine Pen Needle

- Pathway: 510(k) (Special)
- Applicant: Stat Medical Devices, Inc.
- Decided: Oct 2, 2009 after 88 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 K042917 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042917: Stat Medical Pen Needle, Emergogroup, Inc. (2005) Summary page 1.

## Indications for use
The Stat Medical Super-Fine Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K092016
Methodology: https://510kreport.com/methodology