# K250658: SureFine Pen Needle

- Pathway: 510(k) (Special)
- Applicant: Shina Med Corporation
- Decided: Apr 3, 2025 after 29 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: 6 generations back to K951254 (1995). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152877: SureFine Pen Needle, Shina Med Corporation (2016) Summary page 5.

## Indications for use
SureFine Pen Needle is intended for use with a pen injector for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K250658
Methodology: https://510kreport.com/methodology