# K152877: SureFine Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Shina Med Corporation
- Decided: Jun 7, 2016 after 251 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: 5 generations back to K951254 (1995). 16 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113186: Sterile Insulin Pen Needle, Shina Corp. (2012) Summary page 4.

## Most influential descendants
- K250658: SureFine Pen Needle (2025), 0 descendants of its own

## 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/K152877
Methodology: https://510kreport.com/methodology