# K152410: Top Fine Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Medexel Co.,Ltd
- Decided: Feb 2, 2016 after 160 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: 3 generations back to K973899 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080904: Feel-Fine Insulin Pen Needle, Feel Tech (2008) Summary page 4.

## Indications for use
Top Fine® Pen Needle is intended for use with pen injector device for the subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K152410
Methodology: https://510kreport.com/methodology