# K113186: Sterile Insulin Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Shina Corp.
- Decided: Apr 12, 2012 after 167 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: 4 generations back to K951254 (1995). 15 ancestors in all.
4 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)
- K100812: Ulticare Disposable Pen Needles, Ultimed, Inc. (2010) Summary page 2.
- K090111: Flexpen Needle, Novo Nordisk, Inc. (2010) Summary page 2.
- K100005: BD Pen Needle, Becton, Dickinson and Co. (2010) Summary page 2.

## Most influential descendants
- K210748: Well-life TM Pen Needles, Well-life TM Safety Pen Needles (2022), 1 descendant of its own
- K152877: SureFine Pen Needle (2016), 1 descendant of its own
- K260855: Profoject™ Safety Pen Needles (2026), 0 descendants of its own
- K250658: SureFine Pen Needle (2025), 0 descendants of its own

## Indications for use
ShinaPen® is intended for use with pen injector devices for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K113186
Methodology: https://510kreport.com/methodology