# K250510: Sure-Fine Insulin Syringes

- Pathway: 510(k) (Special)
- Applicant: Shina Med Corporation
- Decided: Oct 15, 2025 after 236 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- 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 K941657 (1994). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210848: Sure-Fine Insulin Syringes, Shina Med Corporation (2022) Summary page 5.

## Indications for use
Sure-Fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.

Source page: https://510kreport.com/device/K250510
Methodology: https://510kreport.com/methodology