# K152879: Sure-Fine Insulin Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Shina Med Corporation
- Decided: Sep 9, 2016 after 345 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: 3 generations back to K941657 (1994). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091167: Shina Insulin Syringe-Including Accu-Sure Insulin Syringes, Shina Corp. (2009) Summary page 4.

## Most influential descendants
- K191531: Sure-Fine Insulin Syringes (2019), 2 descendants of its own
- K210848: Sure-Fine Insulin Syringes (2022), 1 descendant of its own
- K250510: Sure-Fine Insulin Syringes (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K152879
Methodology: https://510kreport.com/methodology