# K191531: Sure-Fine Insulin Syringes

- Pathway: 510(k) (Special)
- Applicant: Shina Med Corporation
- Decided: Sep 6, 2019 after 88 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K941657 (1994). 5 ancestors in all.
2 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)
- K152879: Sure-Fine Insulin Syringes, Shina Med Corporation (2016) Summary page 4.

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

## Recalls of this device
- Jan 19, 2018 · Class II · Z-0266-2023: Insulin syringe retail packages incorrectly labeled as "Short Needle".

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

Source page: https://510kreport.com/device/K191531
Methodology: https://510kreport.com/methodology